Drugs

FDA Says Omthera Petition Already Granted

FDA says that the two requests in a 10/31/14 Omthera Pharmaceuticals petition and 11/2/15 supplement have already been granted by previous agency action. The petition asked that FDA (1) grant Omthera’s request for five-year new chemical entity (NCE) exclusivity for its Epanova (omega-3-carboxylic acids) and (2) not apply the three-part framework and “one-to-many” approach described in the Vascepa exclusivity decision to Epanova.

The agency response says that FDA has already recognized that Epanova is eligible for five-year NCE exclusivity, as reflected in the Orange Book listing for the drug’s NDA. On the second request, the letter says that FDA reached its decision about Epanova’s eligibility based on its conclusion that Epanova’s entire fish oil mixture is both the active ingredient and the active moiety of the drug product. “Prior to Epanova’s approval, the active moiety in Epanova had never been approved; therefore, this active ingredient was considered an NCE when it was approved in Epanova,” the letter says. “Accordingly, the second request in your petition has also already been granted through previous agency action.”

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