VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT
- In a regulatory update submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered Alembic Pharmaceuticals Ltd said of having got nod to market medicines to treat prostate enlargement disease.
In a press-release as submitted by the company to the Indian Bourses, titled - "Alembic Pharmaceuticals receives USFDA Final Approval for Silodosin Capsules, 4 mg and 8 mg," it further read that, Alembic Pharmaceuticals Limited today 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 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.
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