Alembic Pharma gets USFDA nod for generic version of Rapaflo Capsules

The approved Silodosin Capsules are therapeutically equivalent to the reference listed drug product (RLD), Rapaflo Capsules, 4 mg and 8 mg, of Allergan Sales, LLC, Alembic Pharma said in a filing.

Mumbai: Drugmaker Alembic Pharmaceuticals Limited recently announced that the company has received final approval from the US Food & Drug Administration (USFDA) for it's Abbreviated New Drug Application (ANDA) Silodosin Capsules, 4 mg and 8 mg to treat Benign Prostatic Hyperplasia (BPH)

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 alpha1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH).

Read Also: Alembic Pharma international formulations grew 10pc to Rs 646 crore in Q2

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

Alembic now has a total of 108 ANDA approvals (96 final approvals and 12 tentative approvals) from USFDA.

Headquartered in Vadodara, the company is involved in manufacturing pharmaceutical products, pharmaceutical substances and intermediates.

Read Also: Alembic Pharma gets USFDA nod for a generic version of Jadenu, Exjade tablet to treat chronic iron overload