CDSCO Panel Directs Malik Lifesciences to Revise Phase III Trial Protocol for Tamsulosin, Dutasteride, Tadalafil FDC
Written By : Parthika Patel
Published On 2025-10-03 13:47 GMT | Update On 2025-10-03 13:47 GMT
Advertisement
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has directed Malik Lifesciences Pvt Ltd to submit a revised Phase III clinical trial protocol for its proposed Fixed Dose Combination (FDC) of Tamsulosin Hydrochloride IP 0.4 mg/0.4 mg (ER tablet), Dutasteride IP 0.5 mg/0.5 mg (film coated tablet), and Tadalafil IP 2.5 mg/5 mg (film coated hard gelatin capsule), intended for the management of Benign Prostatic Hyperplasia (BPH).
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.