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# More than 1,000 ANDAs Approved in 2019
- URL: https://www.fdaweb.com/more-than-1-000-andas-approved-in-2019/
- Published: 2020-02-19T12:00:00.000Z
- Updated: 2026-09-14T16:03:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146126

CDER Office of Generic Drugs (OGD) director **Sally Choe** says the organization gave final or tentative approval to more than 1,000 ANDAs in calendar year 2019\. Writing in the OGD [annual report](https://www.fda.gov/drugs/generic-drugs/2019-office-generic-drugs-annual-report/?ref=fdaweb.com), Choe says that while the numbers “indicate another accomplished year for the program, we know what truly matters is that our work results in more treatment choices and greater access to affordable medicines for patients.”

OGD approved 110 complex generic drugs in 2019 and 107 applications for first generics of medicines that had no generic competition, including drugs to treat pulmonary arterial hypertension, breast cancer, seizures, depression, and various infections.

Other accomplishments cited in the report were 269 product-specific guidances published along with four new or revised guidances for industry and one Manual of Policies and Procedures; 2,311 complete response letters issued detailing important items that applicants needed to resolve before FDA could grant approval; 3,274 controlled correspondence inquiries received from industry; 105 pre-ANDA meeting requests received, and more than 10,000 external stakeholders participated in six meetings and workshops to educate and inform about GDUFA and the generic drug program.