FDA Issues Considerations for Submitting Impurity Data for ANDAs

February 9, 2018

The FDA released new information for ANDA applicants on when to submit elemental impurity data, and acknowledged that new guidelines on reporting elemental impurities had slowed approvals in January.

After record generic approvals last year, the agency approved just 25 ANDAs in January, down from 78 in December and 84 in November.

FDA Commissioner Scott Gottlieb called the decline “temporary” on Twitter, attributing it to companies working to implement the new impurity guidelines from Jan. 1. He said the agency expects approvals to pick up as the year continues.

In fiscal 2017, the FDA approved 763 ANDAs, beating the previous year’s record of 651. A further 174 received tentative approval.

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