Alembic Pharmaceuticals 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 alpha-1 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.
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