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  • Will a 'Duodart' generic for prostatate drug be available?
  • by Lee, Hye-Kyung | translator Hong, Ji Yeon | Apr 16, 2025 05:55am
Aprogen's generic drug has been approved for bioequivalence study
Approved in 2021, Duodart succeeded in the combination drug market for urology in Korea
 ¡ã Product photo of Duodart
A generic version of GSK's benign prostatic hyperplasia (BPH) combination product 'Duodart Capsule (dutasteride¡¤tamsulosin hydrochloride),' which drove the success of the combination drug market for urology in Korea, is now under development.

On the 14th, the Ministry of Food and Drug Safety (MFDS) approved an open-label, randomized, two-group, two-period, fasting, single-dose, oral, crossover study in healthy adult male subjects for the biological equivalence evaluation of Aprogen Biologics' 'Dutatams Capsule' and the original 'Duodart Capsule.'

Duodart is a fixed-dose combination of the 5¥á-reductase inhibitor dutasteride and the ¥á‑blocker tamsulosin, which was first approved in Korea in 2021. It was
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