MSN Laboratories gets CDSCO panel nod for FDCs Solifenacin, Mirabegron capsules
New Delhi: In a significant development, MSN Laboratories has got approval from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to manufacture and market a fixed-dose combination of Solifenacin Succinate (as immediate-release tablets) 5mg/5mg plus Mirabegron (as an extended-release tablet) 25mg/50mg capsules for the treatment of Overactive bladder (OAB) symptoms.
This came after the firm presented the proposal for the fixed-dose combination of Solifenacin Succinate (as immediate-release tablets) 5mg/5mg plus Mirabegron (as an extended-release tablet) 25mg/50mg capsules along with the results of bioequivalence (BE) study.
The approval came in line with the condition that the firm should conduct phase IV clinical trial and the phase IV clinical trial protocol should be submitted within 3 months from the date of approval.
Mirabegron plus Solifenacin is a combination of two medicines: Mirabegron and Solifenacin.
Mirabegron is a sympathomimetic beta-3 adrenergic receptor agonist used to relax the smooth muscle of the bladder in the treatment of urinary frequency and incontinence. The activation of beta-3 receptors relaxes detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle, which increases the bladder's storage capacity thereby alleviating feelings of urgency and frequency.
Mirabegron is the first clinically available beta-3 agonist with approval for use in adults with overactive bladder. Its benefits are similar to antimuscarinic medication such as solifenacin or tolterodine. Mirabegron is also indicated to treat neurogenic detrusor overactivity (NDO), bladder dysfunction related to neurological impairment, in children ages three years and older.
Solifenacin is a competitive muscarinic receptor antagonist indicated to treat an overactive bladder with urinary incontinence, urgency, and frequency. It has a long duration of action as it is usually taken once daily. Solifenacin was granted FDA approval on 19 November 2004
At recent SEC meeting for Reproductive & Urology, held at CDSCO headquarters on March 23rd, 2022, the committee thoroughly examined the proposal presented by MSN Laboratories to manufacture and market the FDC drug Mirabegron plus Solifenacin.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the product with the following conditions
1. The firm should conduct a phase IV clinical trial.
2. The phase IV clinical trial protocol should be submitted within 3 months from the date of approval.
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.