Zydus receives DCGI approval of Saroglitazar Mg for treatment of Non-Alcoholic Fatty Liver Disease in India

Zydus Cadila, an innovation-driven global pharmaceutical company today announced that the Drug Controller General of India (DCGI) has approved its New Drug Application (NDA) for Saroglitazar Mg for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD) in India. The prevalence of NAFLD in India is estimated to be nearly 25-30% of the general population. This approval for NAFLD alongwith either of the comorbidities (Obesity, Type 2 Diabetes Mellitus, Dyslipidemia or Metabolic Syndrome) provides the physicians with a viable treatment option. With a once daily, 4mg dose regimen, Saroglitazar Mg will enable better compliance, reduces the pill burden and offers the patient more convenience.

Saroglitazar Mg was launched in India in September 2013, for the treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with type-2 diabetes not controlled by statins alone. In January this year, Saroglitazar Mg received an approval for the treatment of Type 2 Diabetes Mellitus. In March 2020, Saroglitazar Mg had received approval for the treatment of NASH.

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