Drugs

FDA Appeals Court Prepopik Ruling

FDA has appealed to the DC Circuit Court of Appeals a district court ruling remanding to the agency for further consideration a case brought by Ferring seeking five years of exclusivity for its Prepopik (magnesium oxide, anhydrous citric acid, and sodium picosulfate) fixed-dose combination drug, based on the fact that one of the drug’s three ingredients (sodium picosulfate) is a new chemical entity (NCE). Prepopik is a colon cleanse used before a colonoscopy.

FDA approved the drug 7/16/12 and awarded it a three-year period of exclusivity. The company filed a citizen petition asking for a five-year exclusivity based on the inclusion of a new chemical entity in the fixed-dose combination. FDA indicated that it was changing its approach to NCE exclusivity in combination drugs, but would only do so prospectively. Ferring filed suit, alleging that the agency’s decision violated the Administrative Procedures Act by being arbitrary and capricious.

The district court determined that it should have granted Ferring summary judgment in its case after the company presented information that led the court to agree that FDA’s actions were arbitrary and capricious. Although the court remanded the case to FDA for further action consistent with its opinion, the agency chose to ask the appeals court to weigh in.

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