Hyderabad-based Natco Pharma Limited today announced that the US Food and Drug Administration (USFDA) has approved of its Abbreviated New Drug Application(ANDA) for Lansoprozole delayed release capsules of 15 mg and 30 mg dosage. The shipment of this anti-ulcer drug to the US will begin immediately, according to the company.
Lansoprozole is a generic version of Takeda's innovator drug Prevacid and is used to treat stomach ulcers, intestinal ulcers among other related disease conditions as the drug impacts the production of acids in the stomach.
Natco is one of the few Indian players to have qualified for marketing the drug in the US, which has an estimated $ 800 million market for Lansoprozole. Apart from Dr Reddy's laboratories and Wockhardt, the global pharma players like Sandoz, Mylan and Teva also sell their generic versions of the drug in the US market.
Natco currently manufactures and sells the drug in other markets including India.
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