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# Generic Drug Approval Times Drop Sharply
- URL: https://www.fdaweb.com/generic-drug-approval-times-drop-sharply/
- Published: 2018-05-03T12:00:00.000Z
- Updated: 2026-09-15T00:02:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141357

Approval times for generic drugs dropped significantly from the first quarter of the fiscal year (10/2017-12/2017) to the second quarter (1/2018-3/2018), according to CDER’s latest Activities Report of the Generic Drugs Program. The quarterly performance [report](https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm600678.htm?ref=fdaweb.com) shows that the mean tentative approval time dropped from 32.92 months to 20.93 months. The mean full approval time dropped from 41.70 months to 32.24 months, while the median full approval time went from 41.88 months to 22.78 months.

ANDAs awaiting FDA action went from 2,055 in the first quarter to 1,930, while ANDAs awaiting applicant action went up from 1,791 to 1,873.