Drugs

FDA Extends Review of Titan Opioid Addiction Drug

FDA has extended by three months its review of a Titan Pharmaceuticals and partner Braeburn Pharmaceuticals NDA for the maintenance treatment of opioid addiction. The agency has set a new review target date of 5/27.

Following a Psychopharmacologic Advisory Committee meeting in January, FDA requested additional changes to the Risk Evaluation and Mitigation Strategy (REMS) portion of the NDA, which were recently submitted by Braeburn. The agency determined that the submission qualified as a major amendment to the NDA during the review process and elected to extend the action date.

The advisory committee voted 12 to 5 to recommend approval of the implant that is designed to reduce cravings in opioid dependent patients. The agency noted during the meeting that as an implantable formulation, probuphine is intended to be difficult to divert or abuse, and less likely than sublingual buprenorphine formulations to be accidentally ingested by small children. It also offers the possibility of improved adherence to treatment and improved patient convenience.

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