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Aurobindo Receives FDA Approval for Dutasteride and Tamsulosin Hydrochloride Capsules USP, 0.5 mg/0.4 mg

Published: July 18, 2024

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Dutasteride and Tamsulosin Hydrochloride Capsules USP, 0.5 mg/0.4 mg. Aurobindo Pharma’s Dutasteride and Tamsulosin Hydrochloride Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Jalyn Capsules manufactured by Waylis Therapeutics LLC.

Dutasteride and Tamsulosin Hydrochloride Capsules are indicated for:

  • The treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.