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# FDA OKs Alcon-sought Bioequivalence Parameters for Ciprodex
- URL: https://www.fdaweb.com/fda-oks-alcon-sought-bioequivalence-parameters-for-ciprodex/
- Published: 2017-02-13T12:00:00.000Z
- Updated: 2026-09-14T22:06:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137965

FDA has partially approved an Alcon citizen petition that asked the agency to require only *in vivo* bioequivalence testing for ANDAs that cite its Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) sterile otic suspension as the reference-listed drug. The [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-2782-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) said that a recently revised FDA draft guidance that allows an *in vitro* bioequivalence option departs from the agency’s historic practice for topical products such as otic suspensions and diverges from its original 2012 draft guidance. An FDA letter to Alcon says the petition is granted to the extent that it requested the agency to:

- Confirm that an ANDA applicant who lists Ciprodex as the reference-listed drug may not rely on *in vitro* studies alone to establish bioequivalence if the applicant proposes a change in tonicity agent.
- Confirm that an ANDA applicant may not obtain approval if the proposed product contains a different exception excipient from Ciprodex and the applicant cannot establish that the change does not affect safety or efficacy.
- Confirm that an ANDA applicant who proposes different pH adjusters than those used in Ciprodex will not be eligible for approval.