Sun Pharma Gets CDSCO Panel Nod For Alfuzosin-Tadalafil FDC Post-Marketing Study
New Delhi: Drugmaker Sun Pharmaceutical Laboratories Ltd has been granted conditional approval by the Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), to conduct an Active Post Marketing Surveillance (PMS) study of its fixed-dose combination (FDC) drug: Alfuzosin Hydrochloride IP (ER) 10 mg + Tadalafil IP 5 mg uncoated bilayer tablet.
This approval came during the 6th SEC (Urology) meeting held on 22nd July 2025, where the firm presented its Active PMS protocol as required under Form CT-23 dated 25.04.2025.
Following detailed deliberation, the committee recommended the study with specific modifications, stating, "The ED score should be 22 instead of 25 in inclusion criteria. The inclusion criteria should include the patients having the Prostate volume of less than or equal to 60mL. The indication mentioned in the protocol should be in line with the permission granted in Form CT-23."
The SEC further directed that a revised Active PMS protocol incorporating these changes must be submitted to CDSCO for review. Upon approval, the firm must also submit the Active PMS report for further examination by the committee.
The fixed-dose combination combines Alfuzosin, an alpha-blocker that relaxes the muscles in the prostate and bladder, and Tadalafil, a phosphodiesterase-5 (PDE5) inhibitor believed to improve urinary symptoms in benign prostatic hyperplasia (BPH) patients.
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