Drugs

FDA Denies UCB Generic Fintepla Petition

FDA has denied without comment a UCB 5/16 petition asking the agency not to approve an Apotex ANDA for fenfluramine oral solution that cites UCB’s Fintepla (fenfluramine) oral solution as the reference-listed drug, unless specified conditions are met. The denial letter says UCB specifically said the Apotex ANDA labeling should include:

information from the UCB labeling relating to concomitant administration with stiripentol to treat Dravet syndrome; and
dosage modifications and recommendations for patients with hepatic impairment, including those on concomitant stiripentol, as added to the Fintepla labeling in January.

The letter says FDA is required by law to take final action on the petition within 150 days of submission and thus it must act at this time and is denying without comment the specific requests in the petition.

The agency has not made a final decision on whether to approve or not approve any ANDA for a generic form of Fintepla, the letter says. “FDA’s decision to approve or not approve a specific application will be based on the particular facts that are applicable to the application at the time,” it says.

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