Last Updated on August 22, 2025 by The Health Master
CDSCO
Central Drugs Standard Control Organisation approval (CDSCO approval) with conditions has been granted to Sun Pharmaceutical Laboratories Ltd to move forward with a significant post-marketing surveillance (PMS) study.
This study focuses on fixed-dose combination (FDC) drug designed to address two common health issues in men:
- Benign Prostatic Hyperplasia (BPH) and
- Erectile Dysfunction (ED).
The FDC drug is the combination of Alfuzosin Hydrochloride IP (ER) 10 mg with Tadalafil IP 5 mg.
This conditional approval from the Subject Expert Committee (SEC) under the CDSCO marks an important step toward new standards of treatment available to a large range of patients.
Understanding the role of the drug’s Components:
The new FDC drug has two distinct layers of drugs meant to work together.
Alfuzosin:
Alfuzosin is an alpha-blocker that relaxes the smooth muscles in the prostate gland and the bladder neck.
Ultimately, this relaxation helps to increase urinary flow and reduce the symptoms associated with BPH, such as frequent urination, urgency, and a weak stream.
Tadalafil:
A phosphodiesterase-5 (PDE5) inhibitor, Tadalafil is commonly known for its use in erectile dysfunction.
Further, it also shows results in improving urinary symptoms in men with BPH.
The combination of these two powerful drugs is what makes this new drug give desired results.
Conditions and Future Steps
The SEC’s decision, which came out during its 6th Urology meeting on July 22, 2025, was not without specific conditions.
The committee has gone through Sun Pharma’s Active PMS protocol and recommended several important modifications to ensure the study is both safe and effective.
Sun Pharma is now required to submit a revised protocol with details of the changes to the CDSCO, which were highlighted by the SEC during the meeting.
Once the revised protocol is approved, the company can take further steps with the Active PMS study.
After the completion of the study, the final report is to be submitted to the SEC for a final review.
This process ensures that the performance and safety of the drug are thoroughly reviewed and vetted before it comes to the market for its availability.
Q: What is Benign Prostatic Hyperplasia (BPH)?
A: BPH is a non-cancerous enlargement of the prostate gland that can cause urinary issues in men, typically who are more than the age of 50.
Q: Why is this FDC drug important?
A: This FDC drug is a single tablet having the ability to manage both BPH symptoms and ED.
Q: What is the difference between Alfuzosin and Tadalafil?
A: Alfuzosin is an alpha-blocker that primarily targets urinary issues by relaxing muscles, whereas tadalafil is a PDE5 inhibitor that improves blood flow.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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