New Delhi: Alembic Pharmaceuticals on Tuesday said it has received final approval from the US health regulator for its generic Silodosin capsules used in treatment of benign prostatic hyperplasia. The approval by the US Food and Drug Administration (USFDA) for Silodosin capsules is for multiple strengths of 4 mg and 8 mg, the company said in a regulatory filing.
It is therapeutically equivalent to the reference listed drug product Rapaflo Capsules, 4 mg and 8 mg, of Allergan Sales, LLC, it added.
Silodosin capsule is indicated for treatment of the signs and symptoms of benign prostatic hyperplasia.
Citing IQVIA data, the company said Silodosin capsules have an estimated market size of USD 114 million for 12-months ending June 2019.
Alembic now has a total of 108 ANDA approvals (96 final approvals and 12 tentative approvals) from USFDA, the company said.