Drugs

Apicore Wants Specific Study for Penicillamine BE

Apicore Pharmaceutical Private is asking FDA to require that any ANDA or ANDA supplement for penicillamine capsules be approved only if the bioequivalence study supporting such approval uses a bioanalytical method that stabilizes penicillamine from oxidation as soon as the blood samples are collected and measures copper-bound penicillamine, along with the circulating free penicillamine, that appears in plasma. The company petition says that ANDA methods that do not account for stabilization nor the release of copper-bound penicillamine present a risk that the proposed product is not bioequivalent, and hence does not have the therapeutic benefit described in the labeled claims.

Specifically, Apicore asks that any ANDA or supplement for penicillamine capsules be approved only if the bioequivalence study supporting such approval uses a bioanalytical method that introduces a stabilizing agent to minimize the degradation of free penicillamine post sample collection and includes steps to measure penicillamine from penicillamine-copper complex.

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

Read more

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