Drugs

How FDA Calls Some Old Drugs ‘New’

Three Pepper Hamilton attorneys say that an FDA 5/31 decision awarding Amarin Pharma five years of new chemical entity (NCE) exclusivity for its Vascepa overturned the agency’s previous rejection of NCE exclusivity due to a DC federal court ruling that vacated and remanded the FDA administrative decision. “The Amarin case highlights the complexity of determining whether certain drugs that contain a previously FDA-approved active ingredient will be considered a new chemical entity,” the attorneys write.

They cite three relatively recent examples of the agency being asked to modify its NCE policy (1) where the previously approved active moiety is combined with a new chemical entity in a fixed-dose combination; (2) where the subject active moiety is part of a previously-approved multi-component drug mixture; and (3) when the same active moieties have been previously approved, but in a different ratio.

“On the flip side,” the attorneys say, “FDA appears to be taking a stricter view of the core pharmacophore of an active ingredient by stating that esters (whether stable or labile) of a previously approved active moiety are not eligible for NCE status.”

They conclude that given the recent evolution in agency thinking, companies should review court and FDA decisions to devise a strategy to try to obtain NCE exclusivity.

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