New Delhi: Noting the proposed fixed-dose combination (FDC) of 24 mg extended-release (ER) Torsemide and 8 mg Dapagliflozin Tablets is not rational; the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected Syngene's request to conduct the bioavailability/bioequivalence (BA/BE) studies.
This came after the firm presented the Protocol No.: SYNCD-022-24, Version No. 1.00, Date 12-APR-2024 for BA/BE study for export purposes only.
Bioequivalence is determined based on the relative bioavailability of the innovator medicine versus the generic medicine.
Torasemide is a diuretic used to treat hypertension and edema associated with heart failure, renal failure, or liver disease. Torasemide is indicated for the treatment of edema associated with congestive heart failure, and renal or hepatic diseases. Torasemide is also approved to be used as an antihypertensive agent either alone or in combination with other antihypertensives. It acts by reducing the oxygen demand in the medullary thick ascending loop of Henle by inhibiting the Na+/K+/Cl- pump on the luminal cell membrane surface.
Dapagliflozin is a drug that can help with heart failure by reducing the risk of worsening heart failure, cardiovascular death, and hospitalization. It can also improve symptoms of heart failure, such as breathlessness, tiredness, and swelling in the lower legs. Dapagliflozin inhibits the sodium-glucose cotransporter 2 (SGLT2), which is primarily located in the proximal tubule of the nephron.
The diuretic effects of torsemide may be exacerbated by dapagliflozin in the fixed-dose combination (FDC) of 24 mg extended-release (ER) torsemide and 8 mg Dapagliflozin Tablets. The risk of low blood pressure, renal issues, and dehydration may rise as a result.
At the recent SEC meeting for Cardiovascular held on 11th September 2024, the expert panel reviewed Protocol No.: SYNCD-022-24, Version No. 1.00, Date 12-APR-2024 for BA/BE study for export purposes only.
After detailed deliberation, the committee did not recommend permission to conduct the bioavailability/bioequivalence (BA/BE) study for export purposes as the proposed FDC of 24 mg Extended Release (ER) Torsemide and 8 mg Dapagliflozin Tablets is not rational.
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