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FDA Withdraws 216 ANDAs

Nov 16, 2021 | Drug & Biologic Product Submissions, Pharmaceutical

Abbreviated new drug applications (ANDAs) are subject to complying with requirements of FDA annual reporting—often the Q4 submission deadlines including blanket no-change certification (BNCC) or establishment registration (ER). Due to non-compliance with these annual reporting requirements, the FDA is withdrawing 216 of these ANDAs.

Initially, the FDA published in 2020 that 249 ANDAs were non-compliant and offered a notice of an opportunity for a hearing (NOOH).

What is an ANDA?

An abbreviated new drug application or ANDA is submitted to FDA for review and approval of generic drug products. These applications are abbreviated because they are not typically required to provide clinical data to prove their safety and effectiveness. Instead, the drug company will likely prove bioequivalence to an innovator drug that has been approved by FDA. This generic drug needs to deliver the same amount of active ingredients into a bloodstream in the same amount of time as the innovator drug. Innovator drugs are approved with a new drug application or NDA.

In September 2021, FDA released the final guidance: Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers.

FDA Year-End Deadlines

Each year pharmaceutical companies must fulfill annual deadlines to become and remain compliant with the FDA. Each company will have unique schedules for submission to FDA based on application approval dates and updates to labeling and listing information; however, for the most part companies will follow the schedule below for various electronic drug product submissions.

  1. Biologic Lot Distribution Data Report (LDR) – every 6 months
  2. Drug Sample Distribution Report (DSD) – annually by April 1 for previous year
  3. Generic Drug Facility Self ID (SID) – annually in May for upcoming year
  4. Establishment Registration (ER) – update upon change; no changes= Q4 submission
  5. Drug Labeling/Listing (DL) – update upon change; review and update in June and December
  6. Drug Listing Blanket No-Change (BNCC) – Q4 submission

To learn more about annual deadlines, read this blog post.