Alembic Pharmaceuticals Ltd said it received final approval from the United States Food and Drug Administration for the sales of a therapeutic equivalent of Vesicare tablets manufactured by Astellas Pharma US, Inc.
Solifenacin Succin tablets are used for the treatment of overactive bladders. Solifenacin pills improve the patient’s ability to control urination by relaxing the muscles of the bladder.
Solifenacin Succin tablets, in doses of 5 mg and 10 mg, had annual sales of USD 967 million in the US market for the twelve months ending December 2018.
With the latest approval, Alembic has so far received 94 approvals, including 82 final and 12 tentative from the USFDA.
Meanwhile, Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said that it has also received final approval for sales of Solifenacin Succin tablets in the US market.
Headquartered in Vadodara, Alembic manufactures and markets generic pharmaceutical products all over the world.
Established in 1907, it is also one of the leaders in branded generics in India, and has a marketing team of over 5,000 in its home market.