Dr Reddy's launches FDA approved Lansoprazole delayed-release capsules
Hyderabad: Dr. Reddy's Laboratories has launched over-the-counter (OTC) Lansoprazole delayed-release capsules in the US market on May 18, 2012, following Dr Reddy's ANDA approval by the United States Food and Drug Administration (USFDA).
Dr Reddy's will market the product under store brand labels in the US market. The product is the bioequivalent version of Novartis Consumer Health's Prevacid 24 HR capsule which received Rx-to-OTC switch approval with three year exclusivity from the FDA on March 18, 2009. The Prevacid 24 HR capsule market had brand sales of approximately $115 million for the twelve months ending March 2012, according to SymphonyIRI InfoScan Reviews. Dr Reddy's Lansoprazole Capsule in 15 mg strength is available in 14, 28 and 42 count pack size.
