Drugs

Restrict ANDAs for Generic Xipere: Bausch & Lomb

A Bausch & Lomb FDA 11/30 citizen petition asks FDA to refuse to receive and/or refuse to approve any ANDA referencing Xipere (triamcinolone acetonide injectable suspension) that uses a different SCS injector than the approved proprietary SCS Microinjector unless the ANDA includes in vivo studies with clinical endpoints demonstrating that the product as a whole has the same safety and efficacy profile as Xipere. Xipere is indicated for suprachoroidal use to treat macular edema associated with uveitis.

The petition also asks the agency to revise its 2/2023 draft product-specific guidance to require the same restriction and to include syringeability and glide force as physicochemical characteristics required for comparative purposes.

“Xipere was developed as a combination product such that the device component is as important to the safety and efficacy of the product as the drug component,” Bausch & Lomb says. “For that reason, it is critical that any proposed ANDA referencing Xipere have the same safety and efficacy profile as that of the SCS Microinjector used in Xipere….. Absent the same injector, the safety and efficacy of a generic version of Xipere should be demonstrated through in vivo studies and switching studies showing that the product can be used interchangeably with Xipere.”

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