Drugs

Par Sues FDA Over Colchicine Exclusivity Forfeiture

Par Pharmaceutical has filed a lawsuit in DC federal court against FDA seeking reversal of an agency decision that revoked Par’s eligibility for 180-day exclusivity for a generic copy of Takeda’s gout drug Colcrys (colchicine) tablets. On 9/28, the agency informed Par for the first time that it had forfeited eligibility for 180-day exclusivity. It told the company that “[a]lthough Par has maintained a paragraph IV certification with respect to the ’648 patent and the ’297 patent, it has not maintained an uninterrupted paragraph IV certification with respect to any claims within these patents.” In its complaint, Par contends that it maintained uninterrupted Paragraph IV certification with respect to at least claims one and seven of the ’648 patent.

Par says FDA has failed to provide a lawful basis for its decision. It asks the court to declare the agency’s decision was arbitrary, capricious and contrary to law. It also asks for an injunction directing FDA not to approve any other ANDA for colchicine tablets prior to the approval of Par’s ANDA.

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