FDA Is Evolving On Qualifications For 'New Chemical Entity'

Law360, New York (September 7, 2016, 12:27 PM EDT) -- Aparna Nemlekar

N. Nicole Stakleff

Raymond A. Miller When can an old compound be considered new again? Apparently, when the U.S. Food and Drug Administration says so, of course. On May 31, 2016, the FDA awarded Amarin Pharma Inc. five years of new chemical entity ("NCE") exclusivity for Vascepa,[1] overturning their previous rejection of NCE exclusivity due to a District of Columbia decision, which vacated and remanded the FDA's administrative decision.[2] 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.

There are now three relatively...

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