FDA Policy/General

Product Approval Summaries

BIOLOGICS

Protein Sciences has received expanded approval from FDA for Flublok influenza vaccine to treat adults aged 18 years and older. The company says the vaccine is developed using modern recombinant technology, and is the only flu vaccine that is 100% egg-free and highly purified. It adds that the vaccine is now indicated for use in people aged 50 years and older under FDA’s accelerated approval process.

FDA has approved under its accelerated approval regulatory pathway Wyeth Pharmaceuticals’ Trumenba, the first vaccine licensed in the U.S. to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

DEVICES

FDA has cleared a RenovoRx 510(k) for its RenovoCath RC120 catheter, intended for isolating blood flow and delivering fluids, including diagnostic material and therapeutic agents, into selected sites in the peripheral vascular system.

FDA has approved a St. Jude Medical PMA for its TactiCath Quartz irrigated ablation catheter, described by the company as a real-time objective measure of the force that the catheter applies to a patient’s heart wall during an ablation procedure. The device was designed to provide physicians with more control to modify the force during ablation procedures in order to create more effective lesions for patients being treated for paroxysmal atrial fibrillation (AF), according to the company.

HUMAN DRUGS

AstraZeneca has received FDA approval of an NDA for once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for treating adults with Type 2 diabetes. The drug is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate. It is not recommended for patients with Type 1 diabetes or diabetic ketoacidosis, the company says.

FDA has approved a Lannett Co. ANDA for letrozole tablets USP, 2.5 mg, a generic copy of Novartis’ Femara tablets, indicated for treating postmenopausal women with hormone receptor-positive early stage breast cancer after surgery.

FDA has granted final approval to TWi Pharmaceuticals for its ANDA for donepezil hydrochloride tablets USP, 23 mg, a generic equivalent of Eisai Inc.’s Aricept 23mg, indicated to treat Alzheimer’s disease.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome