FDA withdraws more than 200 ANDAs over unsubmitted annual reports

Almost two years after proposing to withdraw nearly 250 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit the necessary annual reports, the US Food and Drug Administration (FDA) on Thursday said it will withdraw 216 of those applications.

The withdrawals follow a notice of opportunity for hearing (NOOH) FDA published in January 2020 that listed 249 applications from 89 drugmakers with delinquent annual reports. (RELATED: FDA seeks to pull nearly 250 ANDAs over unsubmitted annual reports, Regulatory Focus 8 January 2020)

In the intervening months, FDA heard from several companies, including one that requested a hearing for 3 of its applications and 3 companies that submitted annual reports for 8 of their products after the notice was published. As a result, FDA rescinded its proposal to withdraw those 11 ANDAs.

FDA also rescinded its proposal to withdraw 2 ANDAs after being notified that one application had previously been consolidated with another ANDA and that one had been transferred to another manufacturer.

Another 13 companies told FDA they had already asked the agency to withdraw 15 of the ANDAs listed in the notice as the products are no longer marketed. FDA also withdrew several other ANDAs for fixed-dose combination drugs containing codeine phosphate due to missing risk evaluation and mitigation strategy (REMS) reports in April 2021 that were also included in the January 2020 list.

With those ANDAs accounted for, FDA is now withdrawing the remaining 216 applications contained in the January 2020 notice as the ANDA holders did not respond to the NOOH. The withdrawn applications include generic drugs made by Fresenius USA, Wockhardt, Rexall Drug Co., Watson Laboratories, Alra Laboratories, American Therapeutics, Cook Imaging, Valeant Pharmaceuticals, Abbott Laboratories, and others.

Federal Register notice

FDA withdraws more than 200 ANDAs over unsubmitted annual reports

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