Drugs

Acorda Wants FDA Genotoxic Review for Ampyra ANDAs

Acorda Therapeutics is asking FDA to “carefully consider the sufficiency of the applicant’s identification and qualification of potentially genotoxic impurities in reviewing an ANDA referencing its Ampyra (dalfampridine) extended release tablets.” The company petition says that certain potentially genotoxic impurities that may be present in the Ampyra drug substance and/or drug product were identified in the drug’s NDA and during FDA’s review of the application.

To demonstrate Ampyra’s safety, the company says, it “carefully and thoroughly evaluated the genotoxic potential of those impurities and qualified them. Generic versions of Ampyra similarly may be associated with potentially genotoxic impurities that may or may not be the same as those that Acorda identified and qualified.”

The petition says that to ensure the safety of any generic versions of Ampyra, FDA should closely review the adequacy of an ANDA applicant’s identification and qualification of potentially genotoxic impurities. It says that the agency review should include not only the impurities associated with Ampyra or specified in the USP monograph for dalfampridine, but also other impurities that are possible based on each ANDA applicant’s specific synthetic route, formulation, composition, or manufacturing process.

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