Drugs

FDA Approves Serenity SER 120, Denies Ferring Petition

In denying a 11/19/16 Ferring petition asking that it not approve a Serenity Pharmaceuticals NDA for SER 120, a desmopressin nasal spray to treat nocturia in adults, until certain conditions are met, FDA said it approved the NDA 3/3 because it “is satisfied that Serenity presented substantial evidence of effectiveness and that the benefits of SER 120 outweigh the risks when used in accordance with its labeling.”

Ferring had asked that agency approval for SER 120 or any other application for a desmopressin product to treat nocturia be delayed until (1) FDA establishes a consistent interpretation of the standard for effectiveness, particularly for purposes of determining whether the effect of the drug is clinically meaningful, and (2) FDA establishes a consistent interpretation of the standard for safety, particularly actions needed to mitigate the risk of hyponatremia.

The denial letter says that the agency applied the same standard to evaluate whether the treatment effects in pivotal trials for Ferring’s Nocdurna (desmopressin) sub-lingual tablets and Serenity’s SER 120 were clinically meaningful. “Applying the same approval standard to different applications can lead to different regulatory outcomes,” it says. The letter notes that although both are desmopressin products, the data submitted for each product were different, and the petition failed to adequately account for those differences.

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