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Update Pharma Receives Orphan Drug Approval



2/19/2014 9:21:37 AM

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LEBANON, N.J.--(BUSINESS WIRE)--Update Pharma Inc. today announced that the FDA has approved Orphan Drug Status for the use of UPI-928 for the treatment of Acute Myeloid Leukemia (AML). The FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition that affects fewer than 200,000 individuals in the U.S. The first NDA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for the use of that product in the specified indication. The company may also be eligible to receive clinical trial tax incentives (21 CFR 316.20 and 316.21).

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