Headache and Migraine
ProEthic Pharmaceuticals Announces Acceptance of New Drug Application for Migraine
Published in Medical Letter on the CDC and FDA, December 30th, 2007
ProEthic Pharmaceuticals, Inc., a privately funded specialty pharmaceutical company that acquires, develops, licenses and markets niche prescription products, announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's submission of its New Drug Application for PRO-513 for the treatment of migraine headaches. In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA has set the goal date for their review as July 27, 2008.
PRO-513 is a patented formulation of diclofenac potassium powder for oral solution, which utilizes a unique, Dynamic Buffering Technology (DBT(TM)) that has been demonstrated to enhance the pharmacokinetic profile...
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