FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Updates List of Generic-Ready NDAs

Dec. 20, 2017

The FDA updated its published list of off-patent branded drugs with no approved alternatives — one of the first steps the agency took this year as part of its generic drug competition action plan.

First published in June, the agency hopes the list will be used by drugmakers to develop generic competitors — the agency has not received ANDAs for about 10 percent of brand-name drugs whose patents and exclusivity protections have expired. The new list also includes dosage forms, in addition to NDA numbers.

At the time, the FDA announced a new policy of expediting the review of ANDAs until there are at least three generics approved for a given reference drug. The agency cited data linking significant price reductions to the availability of multiple generic options.

The FDA plans to update the list every six months, and excludes NDAs approved within the past year.

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