Drugs

Allergan Petition Seeks to Raise Bar on Generic Viberzi

Allergan has submitted a citizen petition asking FDA to refuse to receive and approve any ANDA that references the company’s NDA for Viberzi (eluxadoline) tablets, indicated for treating adults with irritable bowel syndrome with diarrhea, if the ANDA does not include comparative clinical endpoint data to demonstrate it is bioequivalent to Viberzi.

The petition also asks FDA to publish an updated and revised draft guidance document, consistent with recent and current guidances for other locally acting drugs, to provide recommendations with respect to analyses for approving a generic version of Viberzi. Allergan contends that an eluxadoline ANDA requires endpoint testing of the “locally-acting, poorly permeable drug product.” Additionally, Allergan says that would-be ANDA applicants need to demonstrate that the proposed product contains the same polymorphic form of eluxadoline, or that the product will not be more susceptible to misuse or abuse as a controlled substance compared to the reference-listed drug.

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