NEW DELHI: Drug firm Alembic Pharmaceuticals Tuesday said it has received approval from the US health regulator for Solifenacin Succinate tablets, used for treatment of overactive bladder. The approved products is therapeutically equivalent to the reference listed drug, Vesicare tablets of Astellas Pharma US, Inc.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Solifenacin Succinate tablets in the strengths of 5 mg and 10 mg, Alembic Pharmaceuticals said in a BSE filing.
Quoting IQVIA sales data, the company said, Solifenacin Succinate tablets 5 mg and 10 mg had an estimated market size of USD 967 million for 12 months, ending December 2018.
The company said it now has a total of 94 ANDA approvals from the USFDA.