The USFDA grants orphan drug designation to a drug or biological product intended to treat a rare disease in the United States. “A number of incentives are provided for an orphan-drug such as 7-year marketing exclusivity, tax credits for clinical development costs, exemption/waiver of application fees and assistance from FDA Office of Orphan Products Development (OOPD) during the process,” the company added.
Earlier this month, the USFDA had granted fast track designation to Rhizen Pharmaceuticals SA’s RP6530. Fast track designation is awarded to drugs that treat a serious condition and fill an unmet medical need. Stock of Alembic Pharmaceuticals was at Rs 530.30 on the BSE, up 0.22 per cent from its previous close.