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Clinical Insights: January 3, 2024

Posted on January 3, 2024 By RxStrategies, Inc. -

Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

New Drug/Vaccine Approval

Wainua™ (eplontersen) Injection – New Orphan Drug Approval – December 21, 2023 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved Ionis and AstraZeneca’s Wainua™ (eplontersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN. Wainua™ is the only approved medicine for the treatment of ATTRv-PN that can be self-administered via an auto-injector. <Read More>

Filsuvez® (birch triterpenes) Topical Gel – formerly Oleogel-S10 – New Drug Approval – December 19, 2023 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, announced that the U.S. Food and Drug Administration (FDA) approved Filsuvez® (birch triterpenes) topical gel for the treatment of partial thickness wounds in patients 6 months and older with Junctional Epidermolysis Bullosa (JEB) and Dystrophic Epidermolysis Bullosa (DEB). Filsuvez® is the first approved treatment for wounds associated with JEB, a rare, moderate-to-severe form of EB with blisters beginning in infancy. Filsuvez® joined the Chiesi portfolio as part of the agreement reached during the acquisition of Amryt Pharma in January of this year. <Read More>

Alyglo™ (Immune Globulin Intravenous, Human-stwk) 10% Liquid – New Drug Approval – December 17, 2023 – GC Biopharma USA, Inc. announced that the US Food and Drug Administration (FDA) has approved Alyglo™ (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as “G5107B,” for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI). The Alyglo™ pivotal phase 3 clinical study followed FDA guidance for the treatment of patients with PI. <Read More>

New Indication/Dosage/Formulation Approval

Tarpeyo® (budesonide) – New Label Expansion – December 20, 2023 – Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), announced that the U.S. Food and Drug Administration (FDA) has approved Tarpeyo® (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Tarpeyo® was first approved in December 2021 under accelerated approval, based on the surrogate marker of proteinuria. Marking a significant milestone, Tarpeyo® is now the first fully FDA-approved treatment for IgAN based on a measure of kidney function. <Read More>

Padcev® (enfortumab vedotin-ejfv) and Keytruda® (pembrolizumab) – New Label Expansion – December 15, 2023 – Astellas Pharma Inc. (TSE:4503) and Pfizer Inc. (NYSE: PFE) announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved Padcev® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with Keytruda® (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC. <Read More>

Adbry® (tralokinumab-ldrm) Injection – New Label Expansion – December 14, 2023 – LEO Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of Adbry® (tralokinumab-ldrm) to include pediatric patients aged 12-17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry® is the first and only FDA-approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, one of the key drivers of AD signs and symptoms. <Read More>

Nexletol® (bempedoic acid) and Nexlizet® (bempedoic acid and ezetimibe) Tablets – New Label Expansion – December 13, 2023 – Esperion (NASDAQ: ESPR) announced that the U.S. Food and Drug Administration (FDA) has approved an updated LDL-cholesterol lowering indication for Nexletol® and Nexlizet® to include the treatment of primary hyperlipidemia as a qualifier for existing approved populations. Additionally, the maximally tolerated qualifier for statin use has been removed, and the prior limitation of use stating “the effect of Nexlizet® or Nexletol® on cardiovascular morbidity and mortality has not been determined” has also been removed. <Read More> 

Trogarzo® (ibalizumab-uiyk) Injection – New Label Expansion – December 12, 2023 – Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, announced that the United States Food and Drug Administration (FDA) has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) push loading dose for Trogarzo® (ibalizumab-uiyk). IV push is a method by which the undiluted medication is “pushed” by syringe for faster administration into the body’s circulation and is designed to make Trogarzo® administration easier and more convenient for people with HIV and their health care providers. As a result, more clinics will be able to initiate new patients and provide ongoing treatment. <Read More>

New Drug Shortage

December 28, 2023

December 27, 2023

December 21, 2023

December 20, 2023

December 19, 2023

Updated Drug Shortage

January 02, 2024

December 28, 2023

December 27, 2023

December 22, 2023

December 21, 2023

New Drug Recall and Safety Alerts

4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection by Hospira, Inc. – New Voluntary Recall – December 26, 2023 – Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP Abboject® Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield® Abboject® Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP Lifeshield® Abboject® Glass Syringe, 1 mg/10 mL to the user level. The recall was initiated due to the potential for presence of glass particulate matter, identified during product inspection. <Read More>

Americaine® 20% Benzocaine Topical Anesthetic Spray by Insight Pharmaceuticals – New Voluntary Recall – December 22, 2023 – Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray to the consumer level. While benzene is not an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products, a recent review by our manufacturer and their third-party lab found that a sample from one lot of the product showed a low level of benzene came from the propellant that sprays the product out of the can. <Read More>

Bleomycin for Injection, USP 15 Units Single Dose Onco-Tain™ Glass Fliptop Vial by Hospira, Inc. – New Voluntary Recall – December 22, 2023 – Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Bleomycin for Injection, USP 15 units Single Dose Onco-Tain™ Glass Fliptop Vial, lot BL12206A, to the user level. The recall was initiated due to a confirmed customer report for the presence of glass particulate within a single vial. <Read More>

New Generic/Biosimilar Approval and Launch

Condylox Gel 0.5%® – New Generic Approval – December 4, 2023 – Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, announced that its partner Padagis US LLC has received final approval from the United States Food & Drug Administration (FDA) on its abbreviated New Drug Application (ANDA) for Podofilox Gel, the first drug product generic to Condylox Gel 0.5%® in the U.S. Podofilox Gel is an antimycotic drug for the topical treatment of external genital and perianal warts. <Read More>

Clinical and Pharmacy News

A Popular Asthma Inhaler is Leaving Pharmacy Shelves. Here’s What You Need to Know – December 30, 2023 – Some asthma patients may start out the new year scrambling for their go-to inhaler – at least that’s the concern as Flovent, a popular drug, leaves store shelves starting in January. Earlier this year, drugmaker GSK announced it’s discontinuing Flovent in 2024. There is a generic version to take its place, but some doctors worry patients could be left in the lurch as they sort out how to get the new medication covered by insurance. <Read More>

Controlled Substance Transfers: Ensuring Internal Management From Site to Site – December 22, 2023 – Controlled substance transfers are occurring at a higher rate as health systems create their own ecosystems to combat medication shortages. Whenever medications are purchased from any entity, a process must be followed that allows for tracing the medications with ease. When it comes to controlled substances, every individual vial, syringe, or bag must be easily tracked. When pharmacies order medication from traditional distributors, the process is rather automated and straight forward. However, when alternative or home-grown methods of acquiring controlled substances are utilized, additional review of the ordering process, completion of forms, transportation, and receipt of the medication must be put under the microscope to ensure the Code of Federal Regulations (CFR) Title 21 and state regulations are followed. <Read More>

Senate Inquiry Reveals Widespread Flaws in Maintaining Pharmacy Customer Data Privacy – December 22, 2023 – Results of a new inquiry conducted by the Senate Finance Committee revealed major flaws regarding how pharmacy chains protect, or fail to protect, customer data. The inquiry, helmed by Senate Finance Committee Chair Ron Wyden (D, Oregon), Representative Pramila Jayapal (D, Washington), and Representative Sara Jacobs (D, California), found that unless a state law is established that requires it, major pharmacy chains do not need a warrant to share prescription data and other health records with law enforcement agencies. The pharmacies to which these findings apply include household names such as CVS Health, Walgreens Boots Alliance, Cigna, Optum Rx, Walmart Stores, the Kroger Company, Rite Aid Corporation, and Amazon Pharmacy. <Read More>

FDA Warns Consumers Not to use Counterfeit Ozempic® (semaglutide) Found in U.S. Drug Supply Chain – December 21, 2023 – FDA continues to investigate counterfeit Ozempic® (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057 as pictured below. Some counterfeit products may still be available for purchase. <Read More>

The Role of Pharmacists in HIV Care Continues to Expand – December 21, 2023 – HIV affects 1.2 million people in the United States. Despite the development of effective agents for treatment and prevention of HIV, current rates of viral suppression, pre-exposure prophylaxis and linkage to care fall short of the goals set by the CDC for ending the HIV epidemic. Additionally, the presence of pharmacists in specialty settings, including HIV, has expanded in recent years. Clinical pharmacists are essential components of the interdisciplinary team by providing comprehensive medication management to this complex patient population. <Read More>

340B in the News

AHA Files Friend-of-the-Court Brief Defending Louisiana 340B Contract Pharmacy Law – December 27, 2023 – AHA filed a friend-of-the-court brief in support of a Louisiana law that prohibits drug companies from denying Louisiana hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies. PhRMA and AstraZeneca challenged the state law as preempted by the federal law that created the 340B program, and AHA asserts that their challenge should be rejected. “PhRMA and AstraZeneca cannot demonstrate that Congress intended to create or occupy any field through its 340B legislation,” the brief states. <Read More>

New HRSA 340B Program Resource Asserts Agency’s Position on “Patient” Definition – December 21, 2023 – On December 14, 2023, Health Resources & Services Administration (HRSA) announced a new resource on the 340B Program website compiling resources associated with the 340B Program definition of “patient.” The website is available here. While the HRSA website compiling patient definition resources is new, none of the content is new. The website only provides links to existing HRSA and Apexus materials. The website makes clear that HRSA’s position is that it continues to rely on its 1996 guidance in interpreting the 340B Statute’s use of the term “patient.” The timing of this new resource page in connection with last month’s decision in the Genesis case is likely not coincidental, as many 340B covered entities and other 340B Program stakeholders have been closely evaluating the 340B Program definition of “patient” following that decision. <Read More>