Drugs

FDA Denies Acorda Petition on Ampyra ANDAs

FDA has denied an Acorda Therapeutics petition that asked the agency 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.

FDA’s denial letter said it would not “apply unusual scrutiny to certain ANDAs or require ANDA applicants to satisfy purity specifications appearing in a proposed, but not yet adopted, monograph of the United States Pharmacopeia (USP).” The agency said the USP proposed monograph for dalfampridine includes acceptance criteria for three potentially genotoxic impurities, and the petition suggested the agency should ensure the impurities are treated by any ANDA applicant as potentially mutagenic impurities and thus controlled at specific levels. FDA disagreed with this suggestion, adding that it does not currently have information to classify the three impurities as potentially mutagenic.

“Second,” FDA continued, “a proposed USP monograph has no legal or regulatory effect on a pending NDA or ANDA. Therefore, although FDA may consider the appropriateness of proposed USP specifications, the agency need not apply acceptance criteria from the revision to the pending USP monograph for dalfampridine to any ANDA referencing Ampyra as its [reference-listed drug], or to otherwise treat these three identified substances as genotoxic or mutagenic impurities.”

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