Drugs

Panel to Weigh OTC Phenylephrine Efficacy

FDA has announced a 4/12 Nonprescription Drugs Advisory Committee meeting to discuss the adequacy of efficacy data available for over-the-counter (OTC) use of oral phenylephrine as a nasal decongestant. Panel members are also scheduled to discuss whether oral nasal decongestants phenylephrine hydrochloride and phenylephrine bitartrate should be reclassified as not “Generally Recognized as Safe and Effective” due to lack of efficacy, according to an agency notice.

There has reportedly been growing evidence to question the effectiveness of the OTC phenylephrine-containing products. A 2015 citizen petition urged FDA to issue a final rule removing oral phenylephrine from the OTC Nasal Decongestant Drug Products final monograph and to remove phenylephrine bitartrate from a 2006 amendment to the monograph because the ingredients are not effective. The petition, which was submitted by two University of Florida professors, cites four studies that demonstrate that phenylephrine “is no more effective than placebo in decreasing nasal congestion and increasing the dose fourfold did not provide additional benefit.”

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