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).
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.