Bisoprolol, Telmisartan, Chlorthalidone FDC: CDSCO asks Windlas Biotech to submit new BE protocol
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined Windlas Biotech to submit a fresh bioequivalence (BE) protocol with a larger number of subjects for the proposed fixed-dose combination (FDC) Bisoprolol Fumarate IP plus Telmisartan IP plus Chlorthalidone IP (2.5mg/5mg/10mg plus 20mg/40mg/80mg plus 6.25mg/12.5mg/12.5 mg) uncoated tablets.
This came after the firm presented the proposal along with a justification for sample size before the committee.
The committee observed high intra-subject variability, i.e., more than 30% for telmisartan in the BE study report.
Bisoprolol is a beta-blocker medicine used to treat high blood pressure (hypertension) and heart failure. If you have high blood pressure, taking bisoprolol helps prevent future heart disease, heart attacks, and strokes. Bisoprolol is also used to prevent chest pain caused by angina.
Telmisartan is used alone or in combination with other medications to treat high blood pressure. Telmisartan is also used to decrease the chance of heart attack, stroke, or death in people 55 years of age or older who are at high risk for cardiovascular disease.
Chlorthalidone, a 'water pill,' is used to treat high blood pressure and fluid retention caused by various conditions, including heart disease. It causes the kidneys to get rid of unneeded water and salt from the body into the urine.
At the recent SEC meeting for Cardiovascular held on 17th September 2024, the expert panel reviewed the proposal along with justification for sample size for the cardiovascular drug FDC Bisoprolol Fumarate plus Telmisartan plus Chlorthalidone IP uncoated tablets.
After detailed deliberation, the committee opined that the firm should submit a fresh BE Protocol with more number of subjects to CDSCO for further review by the committee.
