Last Updated on December 31, 2023 by The Health Master
New Delhi: Pharmaceutical major, Cipla has got a green signal 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 conditional on the firm conducting the Phase IV clinical trial study and submitting the study protocol to CDSCO for review by the SEC within three months of approval.
This came after the firm presented its proposal along with a bioequivalence (BE) study report conducted for export purposes as well as justification for the Phase III clinical trial waiver.
In addition, the firm notified that the product is already approved in countries like Europe and the 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 30, the expert panel reviewed the proposal along with the BE study report conducted for export purposes as well as the justification for the Phase III clinical trial study waiver of the FDC drug Solifenacin Succinate 6mg plus Tamsulosin HCl 0.4mg.
Following extensive deliberation, the committee recommended that permission be granted to manufacture and market the FDC drug Solifenacin Succinate 6 mg plus Tamsulosin HCl 0.4 mg, subject to the completion of the Phase IV clinical trial study.
The committee also asked the firm to submit the study protocol within three months from the date of approval to CDSCO for further evaluation.
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