Drugs

Avadel Wants Desmopressin Requirements

Avadel Specialty Pharmaceuticals, which markets Noctiva (desmopressin acetate) nasal spray for treating nocturia due to nocturnal polyuria, is asking FDA to impose requirements on NDAs for desmopressin acetate products with that indication, including a resubmitted Ferring NDA for its Nocturna (desmopressin acetate). In its 5/18 petition, Avadel asks that the agency:

refrain from approving any NDA for a desmopressin acetate product for treating nocturia due to nocturnal polyuria, including Ferring’s pending NDA, unless the application includes data from at least two clinical trials in a subject population that is representative of likely product users;
establish a standard for demonstrating effectiveness for a drug product to treat nocturia due to nocturnal polyuria that requires meeting appropriate primary and secondary endpoints, and that includes using a validated patient reported outcome and taking into consideration the data that demonstrated Noctiva effectiveness, and not approve any desmopressin NDA that does not meet the criteria;
establish criteria for bioavailability and variability of absorption for a desmopressin drug for treating nocturia due to nocturnal polyuria, which criteria take into account the approved dosage form of Noctiva, an inhaled metered dose spray;
refrain from approving Ferring’s desmopressin NDA unless it includes data from the risk mitigation studies recommended at a 1/12/15 advisory committee meeting and in a 2015 complete response letter to address concerns about using the Ferring drug in real-world conditions; and
refrain from approving Ferring’s desmopressin NDA unless Ferring has provided patent certifications required under the Federal Food, Drug, and Cosmetic Act and its regulations, including specifically patents listed for Noctiva with the appropriate notices.

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