Welcome to the August edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.
New Drug Approvals
Adlyxin™ (lixisenatide) – July 28, 2016 – The U.S. Food and Drug Administration approved Adlyxin™ (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise in adults with type 2 diabetes. Adlyxin™ is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. Read More.
Xiidra™ (lifitegrast) – July 12, 2016 – The U.S. Food and Drug Administration approved Xiidra™ (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease. Xiidra™ is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonist, approved by the FDA for dry eye disease. Dry eye disease includes a group of conditions in which the eye does not produce an adequate volume of tears or when the tears are not of the correct consistency. Read More.
Epclusa® (sofosbuvir and velpatasvir) – June 28, 2016 – The U.S. Food and Drug Administration approved Epclusa® to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa® is approved for use in combination with the drug ribavirin. Epclusa® is a fixed-dose combination tablet containing sofosbuvir (Sovaldi®), a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV. Read More.
Vaxchora™ (cholera vaccine, live, oral) – June 10, 2016 – The U.S. Food and Drug Administration approved Vaxchora™, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora™ is the only FDA-approved vaccine for the prevention of cholera. Vaxchora™ is a live, weakened vaccine that is taken as a single, oral liquid dose of approximately three fluid ounces at least 10 days before travel to a cholera-affected area. Read More.
Zinbryta (daclizumab) – May 27, 2016 – The U.S. Food and Drug Administration approved Zinbryta™ (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta™ is a long-acting injection that is self- administered by the patient monthly. RxS Clinical Insight: Daclizumab was formerly marketed under the trade name Zenapax to prevent acute rejection kidney transplants but marketing was discontinued in 2009 due to lack of market demand. Read More.
Ocaliva™ (obeticholic acid) – May 31, 2016 – The U.S. Food and Drug Administration granted accelerated approval for Ocaliva™ (obeticholic acid) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA. PBC is a chronic, or long lasting, disease that causes the small bile ducts in the liver to become inflamed, damaged and ultimately destroyed. RxS Clinical Insight: Ocaliva™ was approved this orphan drug status. Read More.
Afstyla® [Antihemophilic Factor (Recombinant), Single Chain] – May 26, 2016 – CSL Behring announced that the U.S. Food and Drug Administration has approved Afstyla® [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A. Afstyla® is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting protection from bleeds with two to three times weekly dosing. In clinical trials, patients undergoing prophylaxis with Afstyla® experienced a median annualized spontaneous bleeding rate (AsBR) of 0.00. Once activated, Afstyla® is identical to natural factor VIII. Read More.
Tecentriq™ (atezolizumab) – May 18, 2016 – The U.S. Food and Drug Administration approved Tecentriq™ (atezolizumab) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product in its class (PD-1/PD-L1 inhibitors) approved to treat this type of cancer. Read More.
Nuplazid™ (pimavanserin) – April 29, 2016 – The U.S. Food and Drug Administration approved Nuplazid™ (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. Read More.
New Formulation Approvals
Sustol® (granisetron) – August 10, 2016 – Heron Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Sustol® (granisetron) extended-release injection. Sustol® is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. Read More.
Flonase® Sensimist™ (fluticasone furoate) – August 2, 2016 – GSK Consumer Healthcare announced that the U.S. Food and Drug Administration (FDA) has approved Flonase® Sensimist™ Allergy Relief (fluticasone furoate, 27.5 mcg spray) as an over-the-counter (OTC) treatment for symptoms associated with seasonal and perennial allergies. Previously available by prescription as Veramyst®. Read More.
Qbrelis™ (lisinopril) – July 29, 2016 – Silvergate Pharmaceuticals, Inc. announced that the U. S. Food and Drug Administration (FDA) approved Qbrelis™ (Lisinopril) Oral Solution, the first and only FDA-approved Lisinopril oral solution. Qbrelis™ is indicated for the treatment of hypertension (high blood pressure) in adult patients and pediatric patients 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults. Read More.
Viekira XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) – July 25, 2016 – AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved Viekira XR™ (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. Viekira XR™ is a once-daily, extended-release co-formulation of the active ingredients in Viekira PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). Read More.
Relistor® (methylnaltrexone bromide) – July 19, 2016 – Valeant Pharmaceuticals International, Inc. and Progenics Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Relistor® (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Valeant expects to commence sales of Relistor® Tablets in the U.S. in the third quarter of 2016. Read More.
Repatha® Pushtronex™ (evolocumab) – July 11, 2016 – Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha® (evolocumab) Pushtronex™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option. The Pushtronex™ system is a hands-free device designed to provide 420 mg of Repatha® in a single dose. Read More.
Differin™ (adapalene) – July 8, 2016 – The U.S. Food and Drug Administration (FDA) approved Differin™ Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin™ Gel 0.1% is approved for use in people 12 years of age and older. Read More.
Syndros™ (dronabinol) – July 05, 2016 – Insys Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, Syndros™, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (“THC”). Syndros™ is approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Read More.
Kovanaze™ (tetracaine HCl and oxymetazoline HCl) – July 12, 2016 – St. Renatus, LLC, announced it received U.S. Food and Drug Administration (FDA) approval on June 29, 2016 for its first product, a new dental anesthetic, Kovanaze™ (tetracaine HCl and oxymetazoline HCl) Nasal Spray. This is the first product that allows for dental anesthesia to be administered through a nasal spray without using a needle. Read More.
Rayaldee® (calcifediol) – June 21, 2016 – OPKO Health, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Rayaldee® (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Rayaldee® is a patented extended release product containing 30 mcg of a prohormone called calcifediol (25-hydroxyvitamin D3). Read More.
GoNitro™ Viscous (riboflavin 5’) – June 14, 2016 – Espero Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved GoNitro™ (nitroglycerin) sublingual powder for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. With this approval, GoNitro™ is the first and only short-acting nitrate in a stabilized crystal granule form available in single dose packets. Read More.
Byvalson™ (nebivolol and valsartan) – June 6, 2016 – Allergan plc, announced the approval of Byvalson™ (nebivolol and valsartan) 5 mg/ 80 mg tablets, by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension to lower blood pressure. Byvalson™ is the first and only fixed-dose combination (FDC) of a beta blocker (BB) and angiotensin II receptor blocker (ARB) available in the U.S. Read More.
Jentadueto® XR (linagliptin/metformin extended-release) – May 31, 2016 – The U.S. Food and Drug Administration (FDA) approved Jentadueto® XR (linagliptin and metformin hydrochloride extended-release) tablets for the treatment of type 2 diabetes (T2D) in adults. Read More.
Probuphine® (buprenorphine) – May,26 2016 – Titan Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Probuphine® (buprenorphine) implant, the first product for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine. The Probuphine subdermal implant, which utilizes Titan’s proprietary ProNeura™ technology, delivers buprenorphine continuously for up to six months. Read More.
Doryx® MPC (doxycycline hyclate delayed-release tablets) – May 23, 2016 – Mayne Pharma Group Limited announced it received U.S. Food and Drug Administration (FDA) approval for Doryx® MPC (doxycycline hyclate delayed-release tablets) in 60mg and 120mg dose strengths. Doryx MPC is a new formulation that incorporates a modified polymer coat designed to further retard the release of doxycycline in the acidic environment of the stomach. Read More.
Ameluz® (aminolevulinic acid) – May 16, 2016 – Biofrontera AG, announced that the U.S. Food and Drug Administration (FDA) has granted approval of its combination topical prescription drug Ameluz® (BF-200 ALA) and medical device BF-RhodoLED® for photodynamic therapy (PDT) treatment of mild to moderate actinic keratosis (AK) on the face and scalp. Read More.
Fycompa® (perampanel) – May 2, 2016 – Eisai Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Fycompa® (perampanel) CIII Oral Suspension as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. Read More.
Akovaz™ (ephedrine sulfate) – April 29, 2016 – Flamel Technologies announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s New Drug Application (NDA) for Akovaz™ (ephedrine sulfate), a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings. Read More.
Xtampza™ ER (oxycodone) – April 26, 2016 – Collegium Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Xtampza™ ER (oxycodone) extended-release (ER) capsules CII, a twice-daily, oxycodone medication for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Read More.
Triferic® (ferric pyrophosphate citrate) – April 26, 2016 – Rockwell Medical, Inc., announced that the U.S. Food & Drug Administration (FDA) has approved the New Drug Application for Triferic® Powder Packet for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease. Triferic® is the Company’s innovative iron-replacement drug for the treatment of anemia in chronic kidney disease patients receiving hemodialysis. Read More.
Orfadin® (nitisinone) – April 26, 2016 – Swedish Orphan Biovitrum AB (Sobi), announced that the Food and Drug Administration (FDA) has approved Orfadin® Oral Suspension for the treatment of Hereditary Tyrosinemia Type 1 (HT-1). Orfadin® is indicated for use in combination with dietary restriction of tyrosine and phenylalanine. Read More.
Bevespi Aerosphere™ (glycopyrrolate and formoterol fumarate) – April 25, 2016 – AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved Bevespi Aerosphere™ (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Read More.
New Indication Approvals
Keytruda® (pembrolizumab) – August 8, 2016 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Under the FDA’s accelerated approval regulations, this indication for Keytruda® is approved based on tumor response rate and durability of response. Read More.
Dysport® (abobotulinumtoxinA) – August 1, 2016 – Ipsen announced that the U.S. Food and Drug Administration (FDA) has approved Dysport® (abobotulinumtoxinA) for injection for the treatment of pediatric lower limb (PLL) spasticity in children two years of age and older. Read More.
Namzaric® (memantine/donepezil) – July 19, 2016 – Allergan plc and Adamas Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) approved a new, expanded label for Namzaric® (memantine and donepezil hydrochlorides). With the new indication, patients with moderate to severe Alzheimer’s disease, who are currently stabilized on Aricept, donepezil hydrochloride (10 mg), can now start combination therapy directly with Namzaric®. Read More.
Photrexa® Viscous (riboflavin 5’-phosphate in 20% dextran) and Photrexa® (riboflavin 5’-phosphate) – July 19, 2016 – Avedro, Inc., approval from the U.S. Food and Drug Administration (FDA) for Photrexa Viscous, Photrexa and the KXL System used in corneal collagen cross-linking for the treatment of corneal ectasia following refractive surgery, the products’ second indication. Avedro’s photoenhancers, Photrexa® Viscous and Photrexa®, used in conjunction with the KXL System, received an initial indication for the treatment of progressive keratoconus in April 2016, and remains the first and only corneal collagen cross-linking therapy approved in the United States. Read More.
Synjardy® (empagliflozin/metformin) – July 19, 2016 – The U.S. Food and Drug Administration (FDA) approved an expanded indication for Synjardy® (empagliflozin and metformin hydrochloride) tablets to include treatment-naïve adults with type 2 diabetes (T2D). Read More.
Berinert® [C1 Esterase Inhibitor (Human)] – July 18, 2016 – CSL Behring announced that the U.S. Food and Drug Administration (FDA) approved the use of Berinert [C1 Esterase Inhibitor (Human)], its therapy for treating Hereditary Angioedema (HAE) attacks, for use in pediatric patients. This expands the use of Berinert® into all age groups, making it the first and only approved HAE treatment available to patients under 12 years of age. Read More.
Prezista® (darunavir) – July 18, 2016 – Janssen Therapeutics, that the U.S. Food and Drug Administration (FDA) has approved an expansion to the Prezista® (darunavir) U.S. Prescribing Information to include data and results from a study investigating the use of Prezista® during pregnancy and the postpartum period. The recent label update includes dosing recommendations for pregnant women with HIV, and data demonstrates that Prezista® taken with ritonavir was found to be well-tolerated during pregnancy and the postpartum period. Read More.
Prevnar® 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) – Expanded Indication – July 12, 2016 – Pfizer Inc. announced that Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received U.S. Food and Drug Administration (FDA) approval for an expanded age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older, for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae (S. pneumoniae) serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Read More.
Dexilant™, Dexilant™ SoluTab (Dexlansoprazole) – July 11, 2016 – Takeda Pharmaceuticals U.S.A., Inc., announced that the U.S. Food and Drug Administration (FDA) approved Dexilant™ delayed-release capsules and Dexilant™ SoluTab delayed-release orally disintegrated tablets for patients ages 12-17 years old with gastroesophageal reflux disease (GERD). Read More.
Xolair® (omalizumab) – July 6, 2016 – Genentech, announced that the U.S. Food and Drug Administration (FDA) approved Xolair® (omalizumab) to treat moderate to severe persistent asthma in children six to 11 years of age who have had a positive skin test or in vitro reactivity to an airborne allergen and have symptoms that are inadequately controlled with inhaled corticosteroids4. Xolair® is already approved to treat people 12 years and older with allergic asthma. Read More.
Humira® (adalimumab) – June 30, 2016 – AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved Humira® (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. Humira® is now the first and only FDA-approved non-corticosteroid therapy available for adults with non-infectious intermediate, posterior and panuveitis. RxS Clinical Insights: This is an Orphan indication for Humira®. Read More.
Tivicay® (dolutegravir) – June 10, 2016 – ViiV Healthcare announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for dolutegravir 10mg and 25mg oral tablets, reducing the weight limit from at least 40kg to at least 30kg, in ages 6 to less than 12 years old, for the treatment of HIV-1 in children and adolescents. Read More.
Teflaro® (ceftaroline) – May 31, 2016 – Allergan plc announced the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental New Drug Application (sNDA) for Teflaro® (ceftaroline fosamil), granting new indications for pediatric patients 2 months of age to less than 18 years of age with acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae and other designated susceptible bacteria. Read More.
Crestor® (rosuvastatin) – May 27, 2016 – AstraZeneca received U.S. Food and Drug Administration (FDA) approval for a new indication for Crestor® (rosuvastatin) for the treatment of pediatric patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total C, nonHDL-C and ApoB as an adjunct to diet, either alone or with other lipid-lowering treatments. RxS Clinical Insights: This is an Orphan indication for Crestor® (rosuvastatin). Read More.
Invokamet® (canagliflozin/metformin) – May 24, 2016 – Janssen Pharmaceuticals, Inc. (Janssen), announced the U.S. Food and Drug Administration (FDA) has approved Invokamet®, a fixed-dose combination therapy of Invokamet® (canagliflozin) and metformin hydrochloride, for first-line treatment of adults with type 2 diabetes. With this new approval, Invokamet® may now be prescribed in adults with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy. Read More.
Opdivo® (nivolumab) – May 17, 2016 – The U. S. Food and Drug Administration granted accelerated approval to nivolumab (Opdivo®, marketed by Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris®). Read More.
Lenvima® (lenvatinib) – May 13, 2016 – The U. S. Food and Drug Administration (FDA) approved lenvatinib capsules (Lenvima®, Eisai, Inc.), in combination with everolimus, for the treatment of advanced renal cell carcinoma following one prior anti-angiogenic therapy. Lenvatinib was first approved in 2015 for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Read More.
Imbruvica® (ibrutinib) – May 9, 2016 – AbbVie announced the U.S. Food and Drug Administration (FDA) updated the Imbruvica® (ibrutinib) Prescribing Information (PI) to include new data from two Phase 3 trials supporting its expanded use in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The label now includes overall survival (OS) results in previously-untreated CLL/SLL patients from the Phase 3 RESONATETM-2 (PCYC-1115) trial. Read More.
ProAir RespiClick® (albuterol sulfate) – April 29, 2016 – Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick® (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB). Read More.
Viekira Pak® (ombitasvir/paritaprevir/ritonavir; dasabuvir) – April 25, 2016 – AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of Viekira Pak® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A). Read More.
New Generic Drugs
oseltamivir (Tamiflu®) – August 3, 2016 – The U.S Food and Drug Administration (FDA) on August 3, 2016 announced that it had approved the first generic version of Tamiflu (oseltamivir phosphate) earlier this week. The drug is used to treat influenza A and B in patients two weeks of age and older who have had flu symptoms for no more than 48 hours. Read More.
ethacrynic acid (Edecrin®) – August 4, 2016 – Par Pharmaceutical announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for ethacrynate sodium for injection USP, equivalent to ethacrynic acid 50 mg. Ethacrynate sodium is the generic version of Aton Pharma’s Sodium Edecrin® and is used in the treatment of edema. Par’s ethacrynate sodium for injection USP, 50 mg is the first and only generic available. Read More.
mesalamine (Asacol® HD) – August 3, 2016 – Drug firm Cadila Healthcare’s US arm Zydus Pharmaceuticals (USA) Inc., will start selling a generic version of Asacol HD, used for treatment of ulcerative colitis, in the American market from August 1, 2016. Read More.
nilutamide (Nilandron®) – July 18, 2016 – ANI Pharmaceuticals on Monday announced the immediate launch of its generic of Nilandron (nilutamide) tablets following the U.S. Food and Drug Administration’s approval of the drug. This is the first generic of the drug, which is indicated to treat metastatic prostate cancer in combination with surgical castration. Read More.
dofetilide (Tikosyn®) – June 7, 2016 – Greenstone on Friday announced the introduction of its authorized generic of Tikosyn (dofetilide) capsules. The drug is indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week who have been converted to normal sinus rhythm. Read More.
armodafinil (Nuvigil®) – June 1, 2016 – Mylan N.V. announced the U.S. launch of Armodafinil Tablets, 50 mg, 150 mg, 250 mg, a generic version of Cephalon’s Nuvigil®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) and was awarded 180 days of marketing exclusivity for these strengths. Read More.
rosuvastatin calcium (Crestor®) – April 29, 2016 – The U.S. Food and Drug Administration approved the first generic version of Crestor® (rosuvastatin calcium) tablets. Read More.
RxS Clinical Insights: Additional First-Time Generic Drug Approvals can be found here: (Source)
New Drug Shortages
August 10, 2016 – Estradiol Valerate Injection, USP (Currently in Shortage)
August 09, 2016 – Ceftazidime and Avibactam (AVYCAZ) for Injection, 2.5g (Currently in Shortage)
July 20, 2016 – Daunorubicin Citrate Liposome Injection (DaunoXome) (Discontinuation)
July 14, 2016 – Dihydroergotamine Mesylate Injection (Currently in Shortage)
June 02, 2016 – Lindane Lotion, USP 1% (Discontinuation)
New Drug Safety Alerts
FDA Updates Warnings for Fluoroquinolone Antibiotics – July 26, 2016 – The U.S. Food and Drug Administration (FDA) approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections. Read More.
Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR) – June 14, 2016 – The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Read More.
Zecuity (sumatriptan) Migraine Patch – June 13, 2016 – Zecuity manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch. Read More.
Loperamide (Imodium) – June 7, 2016 – The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. Read More.
New Drug Recall Alerts
Oxacillin for Injection – August 19, 2016 – Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent. Read More.
Cetylev (acetylcysteine) – August 18, 2016 – Arbor Pharmaceuticals, LLC announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process. Read More.
0.25 Percent Bupivacaine Hydrochloride – August 5, 2016 – Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail level due to the presence of particulate matter within a single vial. In the event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate. Read More.
Amikacin Sulfate Injection – August 3, 2016 – Teva Pharmaceuticals announced a voluntary recall of seven lots of Amikacin Sulfate Injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for the presence of glass particulate matter. Read More.
Oral Liquid Docusate Sodium by PharmaTech – July 16, 2016 – The U.S. Food and Drug Administration (FDA) is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. Read More.
Clinical and Pharmacy News
What Mylan’s EpiPen Cost Scandal Says About the Drug Price Problem – August 25, 2016 – Following a weeklong firestorm over its EpiPen price hikes—which crescendoed Wednesday with rebukes from Hillary Clinton and the White House—Mylan offered an olive branch on Thursday in the form of a coupon. Read More.
The Complex Math Behind Spiraling Prescription Drug Prices – August 24, 2016 – The soaring cost of prescription drugs has generated outrage among politicians and patients. Some cancer drugs carry price tags of more than $100,000 a year, and health plans are increasingly asking people to shoulder a greater share of the cost. Read More.
Three Ways Pharmacists Can Help Patients Afford EpiPens – August 23, 2016 – At Hartig Drug in Iowa City, Laura Knockel, PharmD, BCACP, and her pharmacist colleagues always look at copays associated with EpiPen prescriptions, which can cost hundreds of dollars. If the patient’s insurance permits it, Knockel and her colleagues will go online and help a patient secure a coupon from the manufacturer to reduce the copay. Read More.
5 Reasons Prescription Drug Prices Are So High in the U.S. – August 23, 2016 – The “most important factor” that drives prescription drug prices higher in the United States than anywhere else in the world is the existence of government-protected “monopoly” rights for drug manufacturers, researchers at Harvard Medical School report. Read More.
Pharmacist Perceptions May Impact Future Use of Biosimilars – August 19, 2016 – A recent survey found that pharmacists prefer naming conventions for biosimilars that includes a nonproprietary proper name with a designated suffix. Furthermore, confidence levels were found to be highest for substituting a biosimilar for the reference biologic when the products shared the same nonproprietary name. Read More.
CMS Releases New Prescription Drug Cost Data – August 18, 2016 – Continuing the commitment to greater data transparency, the Centers for Medicare & Medicare Services (CMS) released privacy-protected data on the prescription drugs that were paid for under the Medicare Part D Prescription Drug Program in 2014. This is the second release of the data on an annual basis, which shows which prescription drugs were prescribed to Medicare Part D enrollees by physicians and other healthcare professionals. Read More.
Migraine in the ER: Treatment Guidelines From the American Headache Society – August 15, 2016 – During a migraine attack, going to the ER can seem like a nightmare come true. The lights are blaring, sounds are loud and unpredictable, and the odors of a hospital turn your already-nauseated stomach. Having an unwelcoming environment exacerbate your symptoms is awful, but that’s a minor irritation compared to having to fight for treatment. Read More.
More and More Pharmacists Are Virtual – August 12, 2016 – Tele-pharmacy, which enables an off-site pharmacist to provide real-time order verification and consultation virtually, began as a way to provide auxiliary hospital pharmacist coverage during off-peak hours—nights and weekends. But more hospital systems are using virtual pharmacists to free health system staff to practice at the top of their licenses. Read More.
Health Information Technology in the Community Pharmacy – August 10, 2016 – Software programs that receive prescriptions and aid in dispensing medications are already in wide use in community pharmacies. These programs help manage inventory, workflow, accounts, and assist in record keeping. But the next wave of pharmacy technology and software is coming—programs that will allow community pharmacies to communicate with local physicians and hospitals in health information exchange (HIE) and give them access to local or regional electronic health records (EHR). Read More.
SLIDESHOW: NACDS TSE 2016 – Hot Pharmacy Technology and Automation Products – August 8, 2016 – Drug Store News editors scoured the show floor at NACDS Total Store Expo for the hottest, most innovative products. Below, DSN presents our Hot Product Picks in the pharmacy technology and automation category. Read More.
Pharmacy Benefit Managers Are Restricting Access to Lots of Drugs Next Year – August 2, 2016 – In the latest bid to control prescription drug spending, the nation’s largest pharmacy benefits managers are again excluding dozens of medicines from their lists of products that are covered by health insurance, which are known as formularies. Read More.
Lack of Pharmacy Access Sends Some Patients Back to The Hospital – August 2, 2016 – Hospital readmissions, a $17 billion annual problem, are higher in rural, remote or smaller communities that sometimes have significantly less access to pharmacies, according to a study published that was one of the first to examine this issue. Read More.
ASCO Issues Guidelines for Chronic Pain in Patients with A History of Adult Cancer – August 4, 2016 – Clinicians who see patients with chronic pain and a history of cancer as an adult should screen them for pain at every visit, according to the American Society of Clinical Oncology (ASCO) Clinical Practice Guideline published in the Journal of Clinical Oncology. Read More.
Hospital Readmissions Linked to Lack of Pharmacy Access – August 4, 2016 – Communities with significantly less access to pharmacies tend to see higher hospital readmission rates, new study results suggest. The study recently published in the Journal of the American Pharmacists Association examined community pharmacy density across 48 rural and urban primary care service areas of Oregon and how it correlated with readmission rates at Oregon’s 58 hospitals. Read More.
New Technology to Fight Opioid Abuse – July 29, 2016 – Pharmacies already calculate the amount of prescription opioids a patient picks up after doctor visits. New technology, called a Morphine Equivalency Calculator, will allow them to get information on the frequency of those prescriptions with a click of a button. Read More.
5 New Best Practices for Medication Safety All Hospital Pharmacists Should Know – July 27, 2016 – The Institute for Safe Medication Practices (ISMP) recently added new best practices for improving patient safety in hospitals. According to ISMP, the purpose of the 2016-2017 Targeted Medication Safety Best Practices for Hospitals is to “identify, inspire, and mobilize widespread national adoption of consensus-based best practices on specific medication safety issues that continue to cause fatal and harmful errors in patients, despite repeated warnings in ISMP publications.” Read More.
Insurers May Share Blame for Increased Price of Some Generic Drugs – July 26, 2016 – With recent reports that drugmakers have sharply raised the prices of some prescription drugs, a reader has written in to ask why a common generic drug is also suddenly costing him more. Another reader has questions about health plans with high deductibles. Here are those readers’ questions, and what I’ve learned about the answers. Read More.
Pharmacy-Benefit Managers Under Pressure – July 23, 2016 – High-priced drugs have everyone ticked off this year – and for good reason. While health-care spending in the U.S. is growing faster than the economy, pharmaceutical costs are growing faster still. New treatments for arthritis and cancer certainly merit a premium, but pharmacy bills can’t grow unchecked. Read More.
Fraud Concerns Emerge as Compounding Drug Sales Skyrocket – July 18, 2016 – Government spending on “compounded” drugs that are handmade by retail pharmacists has skyrocketed, drawing the attention of federal investigators who are raising fraud and over billing concerns. Spending on these medications in Medicare’s Part D program, for example, rose 56 percent last year, with some of the costliest products, including topical pain creams, priced at hundreds or thousands of dollars per tube. Read More.
New Guidelines OK Less Antibiotics for Hospital-Acquired, Ventilator-Associated Pneumonia – July 14, 2016 – Hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) – which account for 20 to 25 percent of hospital-acquired infections – should be treated with shorter courses of antibiotics than they typically are, according to new guidelines released by the Infectious Diseases Society of America (IDSA) and American Thoracic Society (ATS) and published in the journal Clinical Infectious Diseases. Read More.
Managing Aspergillosis: Updated Guidelines from IDSA – July 14, 2016 – The Infectious Diseases Society of America (IDSA) has released updated practice guidelines for the diagnosis and management of aspergillosis, published in Clinical Infectious Diseases. Read More.
There Has to Be Better Prescription Drug Price Transparency – July 11, 2016 – Prescription drug prices doubled between 2005 and 2013 and are continuing to spiral upwards. Legislators have become so concerned about the phenomenon that in eight states – Massachusetts, New York, California, North Carolina, Pennsylvania, Oregon, Vermont and Colorado – they’ve introduced “drug pricing transparency” bills designed to gather detailed internal information from pharmaceutical companies about the cost to manufacture drugs. Read More.
Pharmacy Times Launches New Series, Legislative Focus, for Pharmacists – July 5, 2016) – Pharmacy Times®, the leading media resource for pharmacists and the pharmacy industry, is launching a new monthly column series, Legislative Focus, in response to reader demand for more information on legislative issues affecting pharmacists. Read More.
340B in the News
Loss of Drug Pricing Program Would Hurt At-Risk Patients – August 22, 2016 – The health care industry is undergoing dramatic transformation as we shift from fee-for-service reimbursement to a fee-for-value payment system, promoting the value and outcome of the health care services we deliver. We’re focused on providing the best care for the people we serve, measuring the efficiency of our health care delivery and striving to improve outcomes at a lower cost. Read More.
Human Resources and Services Administration Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers – August 22, 2016 – Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes between 340B Program covered entities and drug manufacturers. Read More.
Are We There Yet? 340B: It Is a Journey, Not a Destination – August 16, 2016 – The Federal 340B Drug Pricing Program: For more than 25 years, it has provided hospitals with vital cost savings to help them to continue providing comprehensive care to underserved patients. The program allows hospitals (and other safety-net providers) to receive discounts from manufacturers on medications dispensed to eligible outpatients. However, the program’s guidelines are complex, leading some hospitals to choose not to participate. Even among hospitals that have already implemented 340B, the program’s complexity can be a barrier to truly optimizing or expanding their participation. Read More.
HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims – August 16, 2016 – On August 12, 2016, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rule making that establishes an administrative dispute resolution process for claims brought by both covered entities and drug manufacturers related to the purchase and sale of covered outpatient drugs pursuant to the 340B Drug Pricing Program. HHS will accept public comments on the proposed rule until October 11, 2016. Read More.
Congress Should Not Cut Drug Program – August 14, 2106 – Via Christi and Ascension are embracing the transformation to new models of care designed to improve health outcomes at a lower cost. But a major obstacle to achieving this transformation is the astronomical price increases of prescription drugs. Read More.
Drug Discount Pricing Program That’s Crucial to JPS is at Risk – August 12, 2016 – JPS Health Network is Tarrant County’s safety-net healthcare provider. That means we treat all sick people regardless of the patient’s ability to pay. A little-known federal statute called the 340B drug discount pricing program helps us care for the neediest in our community, but the pharmaceutical industry wants to curtail it in Washington. Read More.
340B Spotlight: New Report Raises Questions About Eligibility Metric for 340B Hospitals – August 11, 2016 – A new report from the Government Accountability Office (GAO) on how hospitals qualify for certain uncompensated care payments raises questions about how a similar eligibility metric is used to determine 340B eligibility for disproportionate share (DSH) hospitals. The vast majority (81 percent) of 340B sales are through DSH hospitals. Read More.
Six Retail Chains Now Dominate the Still-Booming 340B Contract Pharmacy Business – August 10, 2016 – The pharmacy industry’s role in the 340B Drug Pricing Program continues to expand. Our latest analysis finds that nearly 18,000 pharmacy locations contract with 340B-eligible covered entities. That accounts for more than one in four U.S. retail, mail, and specialty pharmacy locations. Read More.
Mid-Year Medicare 340B Drug Pricing Program Update – August 2, 2016 – Since our last 340B Drug Pricing Program (340B Program) update, the U.S. Centers for Medicare & Medicaid Services (CMS) has issued two regulations, the final Medicaid managed care regulation and a proposed update to the Medicare outpatient prospective payment schedule to implement new site neutrality requirements, that impact the 340B Program. Read More.
Bob Deuell: Federal Government Playing a Dangerous Game with Patient Care – July 22, 2016 – Texas is home to a dedicated network of safety-net hospitals and health care providers that help expand access to care for patients across the Lone Star State, especially in rural areas. These providers do everything they can to maximize limited resources to improve their community’s health and prosperity. Read More.
Don’t Make Cuts to Drug Pricing Program for Needy Patients – July 15, 2016 – The healthcare industry is undergoing dramatic transformation. We’re shifting from fee-for-service reimbursement – receiving payment for each service to a patient – to a fee-for-value payment system, promoting the value and outcome of the healthcare services we deliver. We’re focused on providing the best care for the people we serve, measuring the efficiency of our healthcare delivery and striving to improve outcomes at a lower cost. Read More.
HRSA Wants to Audit Your 340B Program. Are You Ready? 5 Best Practices for Operating a Compliant 340B Program – July 11, 2016 – It’s Friday afternoon and your hospital receives an e-mail from the Health Resources and Services Administration (HRSA), notifying you that your hospital has been selected for a 340B program audit. Are you ready? As part of a team that has helped numerous hospitals prepare for HRSA audits, I can tell you that the single-most important thing any hospital can do to answer yes to that question is to develop a culture of 340B compliance that permeates the entire organization. Read More.