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# 1,021 ANDA Approvals in 2018: Report
- URL: https://www.fdaweb.com/1-021-anda-approvals-in-2018-report/
- Published: 2019-02-27T12:00:00.000Z
- Updated: 2026-09-15T01:08:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143485

The Office of Generic Drugs (OGD) says that in 2018, the first year for GDUFA 2, it approved or tentatively approved 1,021 ANDAs and published more than 250 new or revised guidances, product-specific guidances, and manuals of policies and procedures for stakeholders. In its [annual report](https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm631710.htm?utm%5Fcampaign=Office%20of%20Generic%20Drugs%202018%20Annual%20Report%20Now%20Available&utm%5Fmedium=email&utm%5Fsource=Eloqua), OGD also says it has successfully implemented many of the new GDUFA 2 provisions and those in the FDA Reauthorization Act of 2017.

In her director’s message, **Kathleen Uhl** reports that first generics made up nearly 10% of the 2018 approvals. Of those first generics, she says, 18% were for complex generic drugs, while about 14% of all generics approvals were for complex drugs.