We would like to introduce the RxStrategies Clinical Insights a new concise communication to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place with such topics as new drug product approval information, generic launches, drug product recalls and safety alerts. This will be a frequent communication along with a larger quarterly drug pipeline communication. We welcome your comments and suggestions regarding additional key issues or topics you would like us to cover in the RxStrategies Clinical Insights.
Drug Approvals
Flonase® Allergy Relief (fluticasone propionate) – New Over-the-Counter Drug Approval
July 24, 2014 – GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has approved Flonase® Allergy Relief (fluticasone propionate 50 mcg spray) as an over-the-counter (OTC) treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies. Flonase® Allergy Relief is the first and only over-the-counter nasal spray indicated for relief of all nasal and eye-related allergy symptoms including runny nose, sneezing, itchy nose, nasal congestion and itchy and watery eyes. Flonase® Allergy Relief will be available at full prescription strength and to provide 24-hour non-drowsy allergy relief. Read more.
Zydelig® (idelalisib) – New Orphan Drug Approval
July 23, 2014 – Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Zydelig® (idelalisib) 150 mg tablets for the treatment of three B-cell blood cancers. Zydelig® is indicated in combination with rituximab for patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy and as monotherapy for patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies. Accelerated approval was granted for FL and SLL based on overall response rate. Zydelig® is a first-in-class inhibitor of PI3K delta, a protein that is over-expressed in many B-cell malignancies and plays a role in the viability, proliferation and migration of these cancer cells. Read more.
Targing ER™ (oxycodone/naloxone extended-release) – New Drug Approval
July 23, 2014 – U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Read more.
Ruconest® (C1 esterase inhibitor [recombinant]) – New Orphan Drug Approval
July 17, 2014 – U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Read more.
Octagam® (immune globulin intravenous [human]) – New Dosage Form
July 17, 2014 – Octapharma USA announce the U.S. Food and Drug Administration (FDA) has approved Octagam® 10% for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults. Read more.
Drug Safety
Trelstar® (triptorelin pamoate) – Safety Update
July 11, 2014 -The FDA approved changes to the Warnings and Precautions section of the Trelstar (triptorelin pamoate) drug label.
Read more.
Kadcyla® (ado-transdermal emtansine) – Safety Update
July 11, 2014 – The FDA approved changes to the Warnings and Precautions section of the Kadcyla (abo-transdermal emtansine) drug label. Read more.
Drug Recall
American Health Packaging – Recall of Ibuprofen and Oxcarbazepine
July 18, 2014 – American Health Packaging (Columbus, OH) has voluntarily recalled Ibuprofen Tablets, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets. In addition, American Health Packaging (AHP) has voluntarily recalled Oxcarbazepine Tablets. This voluntary recall is the result of mislabeled inner unit dose blister packaging which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine. http://www.americanhealthpackaging.com/