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news.The FDA has accepted ProEthic Pharmaceuticals' new drug application for PRO-513 for the treatment of migraine headaches. In accordance with the Prescription Drug User Fee Act, the FDA has set the goal date for their review as July 27, 2008.
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PRO-513 is a patented formulation of diclofenac potassium powder for oral solution, which has been demonstrated to enhance the pharmacokinetic profile of diclofenac. This formulation is expected to offer a new safe and efficacious prescription alternative for migraine patients.
Carl Whatley, chairman and CEO of ProEthic, said: “I am ecstatic about this milestone and I am so very proud of our ProEthic team for a job well done.”