Drugs

Pull Mycophenolate Mofetil Draft Guidance: Petition

A petition submitted by the Haynes and Boone law firm asks FDA not to approve any ANDA for a mycophenolate mofetil oral suspension product that relies on only metabolite data to establish bioequivalence to the reference-listed drug (Roche’s CellCept). The firm’s 3/6 petition also asks the agency to change the therapeutic equivalence rating from AB for any previously approved ANDA for a mycophenolate mofetil oral suspension product that relies only on metabolite data to establish bioequivalence to the reference-listed drug (RLD) or that does not include a nasogastric study as required by the current draft guidance.

The petition says that FDA should withdraw its draft guidance on the product and then issue new guidance requiring use of data for both the parent compound and its metabolite to establish bioequivalence with the RLD.

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