Drugs

FDA Mostly Denies Celgene/Abraxis Abraxane Petition

FDA has denied all but one of the requests in a 3/9/15 Celgene/Abraxis BioScience petition asking that the agency refrain from receiving for substantive review or approving any ANDA or NDA that references Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) unless specific conditions stated in the petition are satisfied. Specifically, the petition asked that:

FDA expressly consider the unique characteristics of drug products incorporating nanotechnology when developing standards and requirements for nanomedicines for oncologic indications, including for guidance documents;
any application for a product referencing Abraxane have:

o chemical composition that is qualitatively and quantitatively the same as Abraxane, and physicochemical properties that are equivalent to those of Abraxane;

o bioequivalence of the pharmacokinetic properties, particularly in the rate of paclitaxel tissue distribution and extent of paclitaxel exposure in tissues;

o demonstrated therapeutic equivalence to Abraxane including, where necessary, via adequate and well-controlled comparative clinical studies with appropriate endpoints for each indication

for any 505(b)(2) NDA referencing Abraxane or any other paclitaxel-based formulation, if the applicant product includes nanoparticle formulations, the applicant clinically demonstrates safety and effectiveness as described in the petition.

FDA disagreed with and denied all requests in the petition except that it granted the request to clarify the definition of “free” and “bound” paclitaxel or albumin. The agency letter says the “fraction of free and bound paclitaxel or albumin in reconstituted suspension” should be revised to “fraction of free (in solution) and particle-bound paclitaxel and albumin in reconstituted suspension.”

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