Zydus Group: USFDA grants orphan drug designation to Zydus Cadila's Saroglitazar Mg

Synopsis
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.
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New Delhi: 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.

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