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# How FDA Calls Some Old Drugs ‘New’
- URL: https://www.fdaweb.com/how-fda-calls-some-old-drugs-new/
- Published: 2016-09-13T12:00:00.000Z
- Updated: 2026-09-14T21:31:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136787

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](http://www.lexology.com/library/detail.aspx?g=bb626565-7adc-426b-98c6-64b1c24af9d6&ref=fdaweb.com).

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.