Drugs

FDA Denies Most of Salix Xifaxin Petition

FDA has denied all but two requests in a 2/15/21 petition submitted by Salix Pharmaceuticals asking that the agency not approve any 505(j) ANDA referencing any strength of Xifaxin (rifaximin) tablets as the reference-listed drug unless one of five specified bioequivalence and pharmaceutical equivalence criteria is satisfied. The petition listed these potential studies: studies ensuring equivalent in vivo bioavailabilty at sites of drug action; in vitro dissolution testing for bioequivalence; clinical endpoint bioequivalence studies; systemic safety; and biowaivers. The petition also asked that FDA incorporate the five criteria in a revised draft guidance on rifaximin.

The FDA response explains the agency’s rationale for denying most of the requests. For the request that FDA not permit waivers of the pharmacokinetics and clinical endpoint bioequivalence studies, FDA granted the request to the extent that it plans to make such changes to the draft guidance. The letter also grants the request for revision of the draft-specific rifaximim guidance to the extent that the agency plans to remove the biowaiver options in the guidance.

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