USFDA Approved Silodosin Capsules, 4 mg and 8 mg for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH)

Nov 25, 2019: Alembic Pharmaceuticals  Abbreviated New Drug Application (ANDA) Silodosin Capsules, 4 mg and 8 mg approved by US Food & Drug Administration (USFDA).

This 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 alpha1 adrenergic receptor antagonist) used for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH). 

Estimated market size of  Silodosin Capsules is  US$ 114 million for twelve months ending June 2019 according to IQVIA. https://www.alembicpharmaceuticals.com/wp-content/uploads/2019/11/Press-Release-USFDA-Approval-Silodosin-Capsules-4-mg-and-8-mg-November-2019-1.pdf