Alembic Pharmaceuticals receives USFDA Approval for Solifenacin Succinate Tablets

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.