Alembic Pharmaceuticals receives USFDA Approval for Solifenacin Succinate Tablets

Alembic Pharmaceuticals Limited has announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Solifenacin Succinate Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc. Solifenacin Succinate Tablet is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin Succinate Tablets, 5 mg and 10 mg have an estimated market size of US$ 967 million for twelve months ending December 2018 according to IQVIA. Alembic now has a total of 94 ANDA approvals (82 final approvals and 12 tentative approvals) from USFDA.