CDSCO Panel grants Cadila Healthcare's protocol amendment for Saroglitazar Tablets
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major . Cadila Healthcare's proposal of revised protocol of Phase IV clinical trial of Saroglitazar Tablets 4mg.
This approval came after the drug major firm presented its proposal for the revised protocol of the Phase IV clinical trial of Saroglitazar Tablets 4mg along with the summary of changes in the amended protocol before the committee.
Saroglitazar is a drug for the treatment of type 2 diabetes mellitus and dyslipidemia. It is approved for use in India by the Drug Controller General of India. Saroglitazar is indicated for the treatment of diabetic dyslipidemia and hypertriglyceridemia with type 2 diabetes mellitus not controlled by statin therapy.
Saroglitazar, a dual peroxisome proliferator activated receptor α/γ agonist, approved for diabetic dyslipidemia (DD), is potential therapeutic option for non-alcoholic fatty liver disease (NAFLD).
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