Zydus Cadila gets DCGI approval for Saroglitazar Mg used for NAFLD treatment

Zydus Cadila 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 along with 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.