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# Approval Withdrawn on Upsher-Smith’s ANDA for Zaleplon
- URL: https://www.fdaweb.com/approval-withdrawn-on-upsher-smiths-anda-for-zaleplon/
- Published: 2017-08-16T12:00:00.000Z
- Updated: 2026-09-14T22:41:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139402

*Federal Register* notice: FDA has withdrawn the approval of an Upsher-Smith Laboratories ANDA for zaleplon (reference product: Sonata) capsules, 5 mg and 10 mg. The company requested the withdrawal after being contacted by FDA about concerns with the validity of bioequivalence data from studies conducted by an unnamed contract research organization. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-08-16/pdf/2017-17301.pdf?ref=fdaweb.com).