Zydus receives USFDA Orphan drug designation for Desidustat

Zydus Lifesciences announced that the USFDA has granted Orphan Drug Designation (ODD) to Desidustat, a novel oral HIF-PHI, for the treatment of Sickle Cell Disease (SCD). The USFDA's Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States.

Orphan drug designation by the USFDA for Desidustat, provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and a potential seven-year marketing exclusivity upon the USFDA approval.

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