Zydus Cadila on Thursday said the US health regulator has granted orphan drug designation (ODD) to its Saroglitazar Mg used for the treatment of patients with Primary Biliary Cholangitis (PBC), a liver disease.
The United States Food and Drug Administration (USFDA) has granted ODD to Saroglitazar Mg, Cadila Healthcare said in a regulatory filing.
Zydus Cadila, which is a part of Cadila Group, said orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon USFDA approval.
Pankaj R Patel, Chairman, Zydus Group said : "We are pleased that the USFDA has granted an Orphan Drug Designation apart from the earlier Fast Track Designation to Saroglitazar Mg for the treatment of PBC."