USFDA

Antares Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for 4 mg/0.5 mL and 6 mg/0.5 mL Sumatriptan Injection USP in adults for the acute treatment of migraine and cluster headache when a clear diagnosis has been established. The reference listed drug in the ANDA was GlaxoSmithKline’s Imitrex® Injection. Sumatriptan Injection USP represents the Company’s first ANDA approval of a complex generic and second product approved using the VIBEX® auto injector platform. In accordance with our previously disclosed agreement, Teva Pharmaceutical Industries, Ltd. (Teva) will distribute the product through their U.S. generic division and share the profits equally with Antares Pharma.

Merck , known as MSD outside the United States and Canada, issued  the following statement after the conclusion of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss the results of IMPROVE-IT, an investigational study comparing treatment with VYTORIN® (ezetimibe and simvastatin) to treatment with simvastatin alone in more than 18,000 patients presenting with acute coronary syndromes.

AcelRx Pharmaceuticals, Inc. , a specialty pharmaceutical company focused on the development and commercialization of innovative therapies designed for the treatment of acute pain, reported on the outcome of the ARX-04 (sufentanil sublingual tablet, 30 mcg) pre-NDA meeting held recently with the U.S. Food and Drug Administration (FDA).

The U.S. Food and Drug Administration  approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.

Teva Pharmaceutical Industries Ltd announced that the U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee recommended approval of reslizumab, a humanized anti-interleukin-5 (IL-5) IgG4K monoclonal antibody (mAb), in adult patients aged 18 years and older. Reslizumab is a targeted biologic therapy for the treatment of inadequately controlled asthma in patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based treatment regimen.

U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss in female breast cancer patients undergoing chemotherapy.

Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved BENDEKA™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine. BENDEKA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy in CLL relative to first-line therapies other than chlorambucil has not been established.

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U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency. Kanuma is produced by Alexion Pharmaceuticals Inc., based in Cheshire, Connecticut.

Baxalta Incorporated, a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced today that the U.S. Food and Drug Administration (FDA) has approved VONVENDI [von Willebrand factor (Recombinant)]. VONVENDI is the first and only recombinant treatment for adults living with von Willebrand Disease (VWD).

Drug firm Aurobindo Pharma has received final approval of the US health regulator to manufacture and market its Dexamethasone Sodium Phosphate injection, used to treat various conditions such as severe allergic reactions, arthritis and blood diseases.