# FDA Approves Mayne Pharma's Generic Isotretinoin Mayne Pharma received FDA approval for its generic isotretinoin oral formulation (ANDA076485) on January 19, 2012, marking another competitive entrant in the severe acne treatment market and potentially increasing price competition for branded versions. The approval expands generic options for this potent retinoid, which carries significant clinical importance but faces strict regulatory oversight due to teratogenic risks.