FDA’s denial of a citizen petition from Perrigo Co. PLC preserves an advantage for rival Dr. Reddy's Laboratories Ltd.as both firms prepare to launch generics of Novartis AG’s OTC proton pump inhibitor Prevacid 24HR.
Perrigo Squares Off With Dr. Reddy’s In Lansoprazole Launch
FDA denied Perrigo’s petition that had sought to block Dr. Reddy’s ANDA for generic Prevacid 24HR because it used bioequivalence data for the proton pump inhibitor’s Rx version. Competition between the firms is intensifying as Dr. Reddy’s expands its U.S. OTC presence.