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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for dutasteride and tamsulosin hydrochloride capsules 0.5 mg/0.4 mg. Aurobindo Pharma’s, are an AB-rated generic equivalent to the reference listed drug (RLD), Jalyn Capsules, manufactured by Waylis Therapeutics.
Dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
Dutasteride and tamsulosin hydrochloride capsules has an estimated market size of US $9 Million for the twelve months ending May 2024, as per IQVIA.
