MSN Laboratories gets CDSCO panel nod for FDCs Solifenacin, Mirabegron capsules

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 23^rd, 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.