Cipla Gets CDSCO Panel Nod To Manufacture, Market FDC Tamsulosin plus Solifenacin
New Delhi: Pharmaceutical major, Cipla has got a go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the fixed-dose combination (FDC) drug Solifenacin Succinate 6mg plus Tamsulosin HCl 0.4mg
However, this approval is subject to the condition that the firm should conduct the Phase IV clinical trial study and the study protocol should be submitted within 03 months from the date of approval to CDSCO for review by the SEC.
This came after the firm presented its proposal along with bioequivalence (BE) study report conducted for export purposes as well as justification for the Phase III clinical trial study waiver.
In addition, the firm notified that the product is already approved in countries like Europe and UK.
Solifenacin is a competitive muscarinic receptor antagonist indicated to treat an overactive bladder with urinary incontinence, urgency, and frequency.
Tamsulosin is an alpha-1A and alpha-1B adrenergic receptor antagonist used to treat benign prostatic hyperplasia, ureteral stones, prostatitis, and female voiding dysfunction.
The combination of Tamsulosin and Solifenacin relieves the symptoms of benign prostatic hyperplasia.They work by relaxing the muscle around the bladder exit and prostate gland so urine is passed more easily. This prevents frequent, urgent or uncontrolled urination.
At the recent SEC meeting for Reproductive and Urology held on November 30th, the expert panel reviewed the proposal along with BE study report conducted for export purposes as well as justification for Phase III clinical trial study waiver of the FDC drug Solifenacin Succinate 6mg plus Tamsulosin HCl 0.4mg.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the FDC drug Solifenacin Succinate 6mg plus Tamsulosin HCl 0.4mg with the condition to conduct the Phase IV clinical trial study.
The committee also asked the firm to submit the study protocol within 03 months from the date of approval to CDSCO for further evaluation.
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