Drugs

Require Generic Ozobax Safety Data: Metacel

Metacel Pharmaceuticals is petitioning FDA to require all sponsors of generic forms of its Ozobax (baclofen) oral solution to conduct and provide the same amount of safety data as the agency asked Metacel to perform in support of the supplemental approval of Ozobax. The petition specifically asks FDA to:

require any ANDA sponsor citing Ozobax as the reference-listed drug to conduct and provide safety evidence to support any flavoring ingredient, similar to the data FDA mandated from Metacel, i.e., evidence to support chronic lifetime duration of use for any flavoring ingredient; and
deny any requests from generic drug sponsors to waive the tests.

Metacel says that even though cherry flavoring has historically been generally recognized as safe, FDA had concerns about the flavoring’s safety and determined there was insufficient evidence of safety for Metacel’s intended cherry flavoring. Specifically, it says, FDA seemed to be worried that there was insufficient evidence of safety for the proposed flavor to support chronic (lifetime) duration of drug treatment use.

The petition says FDA “must treat NDA and ANDA sponsors in an equivalent manner by requiring the same essential stability and quality control testing and deny any requests for waiver of such testing by ANDA sponsors. Failure to do so will result in an inability of generic baclofen products to address the same safety issues that were present for Metacel, which could lead to increased patient risk and negative patient outcomes.”

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