Life Sciences Blog

FDA Withdraws 216 ANDAs

Nov 16, 2021 | Drug & Biologic Product Submissions, Life Sciences

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.

About LexisNexis Legal & Professional

LexisNexis Legal & Professional® provides legal, regulatory, and business information and analytics that help customers increase their productivity, improve decision-making, achieve better outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 150 countries with 11,300 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers.

About LexisNexis Reed Tech

LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.

For more information, please visit