Dr. Reddy's Laboratories (RDY) said Monday that it has launched its over-the-counter Lanzoprazole delayed release capsules in the U.S market on May 18 after receiving ANDA approval from the United States Food & Drug Administration.
The company will market the capsules under store brand labels in the U.S. Market.
Lanzoprazole delayed release capsule is the bioequivalent version of Novartis Consumer Health's Prevacid 24 HR capsule which received the Rx-to-OTC switch approval with 3 years exclusivity from the FDA on March 18, 2009.
According to SymphonyIRI InfoScan Reviews, this Prevacid capsule market had brand sales of about $115 million for the twelve months ended March 2012.
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