FDA Denies Mayne Pharma Doryx MPC Petition

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 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.