Drugs

FDA Accepts Astellas sNDA for Overactive Bladder Drug Combo

FDA has accepted for review an Astellas Pharma supplemental NDA that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for treating overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. In the U.S., Myrbetriq (mirabegron) and VESIcare (solifenacin succinate) are individually marketed as monotherapy for treating OAB with symptoms of urge urinary continence, urgency and urinary frequency. The agency has set a user fee review target date of 4/28/2018.

The submission is based on data from the global Phase 3 SYNERGY I, SYNERGY II and BESIDE studies. These included more than 5,000 patients with OAB and evaluated combination therapy with mirabegron and solifenacin succinate compared with each drug as monotherapy and placebo.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

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