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# FDA Withdraws Approval of Upsher-Smith’s Propranolol HCl
- URL: https://www.fdaweb.com/fda-withdraws-approval-of-upsher-smiths-propranolol-hcl/
- Published: 2017-08-30T12:00:00.000Z
- Updated: 2026-09-14T22:45:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139505

*Federal Register* notice: FDA has announced it is withdrawing approval of an Upsher-Smith Laboratories ANDA for propranolol hydrochloride extended-release capsules due to concerns about the validity of bioequivalence data submitted from studies conducted by an unnamed contract research organization. The agency notified the company in 2011\. Subsequently, Upsher-Smith submitted in 2013 new fasted and fed bioequivalence studies to supplement its original ANDA. In 2016, FDA told the company that the fed bioequivalence study failed to meet FDA’s bioequivalence criteria and asked that it voluntarily seek ANDA withdrawal. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-08-30/pdf/2017-18375.pdf?ref=fdaweb.com).