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# FDA Denies Mylan Advair Petition Without Comment
- URL: https://www.fdaweb.com/fda-denies-mylan-advair-petition-without-comment/
- Published: 2018-05-10T12:00:00.000Z
- Updated: 2026-09-15T00:04:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141408

FDA has denied a Mylan 12/5/17 petition asking that the agency not approve any ANDA for a generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) that relies on multiple-batch pharmacokinetic bioequivalence study design unless, after conducting an appropriately rigorous review, the agency concludes that such a study design is valid and will ensure patients receive a robust and reliable therapeutically equivalent product. FDA [denied](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-6750-0008&contentType=pdf&ref=fdaweb.com) the petition without commenting on whether it will ultimately take the requested action.

The denial letter says FDA has made no final determination on whether to approve any ANDA referencing Advair Diskus as its reference-listed drug. And, it says, it has determined that it would not be appropriate to take final agency action on the approvability of a specific aspect of an ANDA before taking final action on the approvability of the entire ANDA.