Drugs

FDA Denies Petitions, Approves Nocdurna

CDER has denied two petitions asking it to deny approval for a Ferring NDA for Nocdurna (desmopressin) sublingual tablets to treat nocturia due to nocturnal polyuria, and has approved the Nocdurna NDA. The denial letter says the petitions were submitted by Serenity Pharmaceuticals and Avadel Specialty Pharmaceuticals. The letter notes that FDA approved an Avadel NDA for Noctiva 3/3/17.

Each petition argued against approving the Nocdurna NDA for varied reasons. Serenity said that there was no reason for FDA to approve another drug that may be less safe and effective for the same clinical indication. Avadel asked that the agency not approve a desmopressin NDA unless specific conditions it called for were met. FDA said it considered all the issues and denied the petitions.

The denial letter says the agency properly applied the same approval standards to both the Nocdurna and Noctiva applications. For the Nocdurna application, the letter says, “FDA is satisfied that Ferring presented substantial evidence of effectiveness and that the benefits of Nocdurna outweigh its risks when used in accordance with its approved labeling.”

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