Submit Revised protocol for Torsemide ER tablets: CDSCO Tells Syngene
New Delhi: Highlighting that proof of concept and criteria are not defined for the overactive bladder in Congestive heart failure (CHF) patients, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Syngene International to submit the proof of concept for clinical trial along with a revised clinical trial protocol of Torsemide extended released (ER) tablets.
This came after the firm presented the proposal to conduct a Phase II clinical trial of Torsemide ER Tablets 24 mg along with the Phase II clinical trial protocol.
Torsemide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine.
Torsemide is used alone or in combination with other medications to treat high blood pressure. Torsemide is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart, kidney, or liver disease.
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