www.fdanews.com/articles/195110-alembics-genericof-allergans-rapaflo-approved-for-hyperplasia
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Alembic’s Generic of Allergan’s Rapaflo Approved for Hyperplasia
December 11, 2019
Alembic Pharmaceuticals received the FDA’s approval for its Silodosin capsules (4mg and 8mg) as a generic to Allergan’s Rapaflo (silodosin).
Silodosin is a selective alpha 1 adrenergic receptor antagonist indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia.
The company now has a total of 108 ANDA approvals, including 96 final approvals and 12 tentative approvals.