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EAST WINDSOR, N.J. – Aurobindo Pharma Ltd. has received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for silodosin capsules, 4 mg and 8 mg. Aurobindo’s silodosin capsules are an AB-rated generic equivalent to the reference listed drug, Allergan Sales, LLC’s Rapaflo.
Silodosin, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin capsules are not indicated for the treatment of hypertension.
Silodosin capsules has an estimated market size of $194 million for the twelve months ending October 2018 according to IQVIA.
