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# FDA Denies Mayne Pharma Doryx MPC Petition
- URL: https://www.fdaweb.com/fda-denies-mayne-pharma-doryx-mpc-petition/
- Published: 2018-03-28T12:00:00.000Z
- Updated: 2026-09-14T23:55:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141090

FDA has denied a Mayne Pharma 11/22/16 petition asking that the agency require specific *in vitro* dissolution criteria as part of the bioequivalence demonstration for any ANDA citing Doryx MPC (doxycycline delayed-release tablets), EQ 60 mg base and EQ 120 mg base as the reference-listed drug (RLD). The FDA [response](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-4047-0005&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says the agency has issued revised draft product-specific guidance on doxycycline hyclate delayed-release oral tablets describing he agency’s recommendations for establishing bioequivalence to the EAQ 60 mg base and EQ 120 base strengths. FDA also approved 3/27 an ANDA for doxycycline hyclate delayed-release oral tablets referencing Doryx MPC as the RLD.

According to the FDA letter, Mayne’s petition did not demonstrate that additional *in vitro* dissolution specifications are necessary to ensure a comparable gastrointestinal profile to Doryx MPC. It further says that Mayne’s proposed tests are not required to document bioequivalence to Doryx MPC.