Drugs

FDA Grants Recro Meloxicam Appeal

FDA has granted a Recro Pharma appeal of the agency’s complete response letter issued for the NDA seeking approval for intravenous meloxicam. The company says the FDA letter said the appeal was granted “specific to the request … that the NDA provides sufficient evidence of effectiveness and safety to support approval.” It also said that before IV meloxicam can be approved and legally marketed, agreed-upon labeling must be negotiated with the agency.

Recro says it is preparing a comprehensive response to FDA that includes proposed labeling that follows the agency guidance in the appeal decision and providing relevant evidence from the filed NDA to ensure safe and effective use of the drug by providers.

According to the company, meloxicam is a long-acting, preferential COX-2 inhibitor that exhibits analgesic, anti-inflammatory, and antipyretic activities. Its IV product was designed using the Alkermes Pharma NanoCrystal platform that enables enhanced bioavailability of poorly water-soluble drug compounds.

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