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# ‘Minor’ CRL for Hikma’s Generic Advair Diskus
- URL: https://www.fdaweb.com/minor-crl-for-hikmas-generic-advair-diskus/
- Published: 2020-09-22T12:00:00.000Z
- Updated: 2026-09-14T16:29:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147706

FDA has sent a complete response letter (CRL) to Hikma Pharmaceuticals on its ANDA for a generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder). The company [describes](https://www.nasdaq.com/articles/hikma-pharma-receives-crl-from-fda-for-generic-advair-diskus-expects-to-get-approval-in?ref=fdaweb.com) the letter as containing “minor” issues and says it is working closely with the agency to quickly address the small number of questions raised in the CRL. Once answered, Hikma could expect to receive a response from FDA within 90 days, it says. Hikma says it now expects to receive approval for its generic Advair Diskus in early 2021.