Drugs

Sage Postpartum Depression Oral Drug Approved

FDA has approved a Sage Therapeutics NDA for Zurzuvae (zuranolone), an oral drug for treating postpartum depression (PPD) in adults. “Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities,” an agency release says. The daily recommended dose for Zurzuvae is 50mg, and it should be taken once every day for 14 days.

Approval was based on data from two randomized, double-blind, placebo-controlled, multicenter studies. “Patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups,” FDA says. “The treatment effect was maintained at Day 42 — four weeks after the last dose of Zurzuvae". On the safety side, the drug’s labeling contains a boxed warning about affecting a person’s ability to drive and perform other potentially hazardous activities. “To reduce the risk of harm, patients should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae,” it says.

Meanwhile, Sage says FDA also issued a complete response letter on the NDA seeking approval as a treatment for major depressive disorder (MDD). The agency told the company that its filing did not provide substantial evidence of effectiveness to support zuranolone for treating MDD.

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