Drug firm Dr Reddy's Laboratories today said it has launched its generic version of lansoprazole delayed-release capsules used for treating acidity and heartburns in the US market.
The company has launched over-the-counter lansoprazole delayed-release capsules in the US market on May 18, 2012 following its abbreviated new drug application (ANDA) approval by the US Food & Drug Administration (USFDA), Dr Reddy's Laboratories said in a statement.
Lansoprazole capsule of the company is available in the strength 15 mg in packs of 14, 28 and 42, Dr Reddy's said.
"The product is the bio equivalent version of Novartis Consumer Health's Prevacid 24 HR capsule, which received Rx-to-OTC switch approval with 3 year exclusivity from the FDA on March 18, 2009," it added.
The process of transferring FDA-approved prescription medications to nonprescription, over-the-counter (OTC) status is called as Rx-to-OTC switch.
Citing data of SymphonyIRI InfoScan Reviews, the company said the capsule had sales of approximately $115 million for the twelve months ending March 2012.
Shares of Dr Reddy's Laboratories were today trading at Rs 1,656.40
In the afternoon trade on BSE, down 0.25% from its previous close.