Alembic Pharmaceuticals receives USFDA final approval for Silodosin Capsules

Alembic Pharmaceuticals announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Silodosin Capsules, 4 mg and 8 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rapaflo Capsules, 4 mg and 8 mg, of Allergan Sales, LLC. Silodosin capsule, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Silodosin Capsules have an estimated market size of US$ 114 million for twelve months ending June 2019 according to IQVIA.

Powered by Capital Market - Live News