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news.Nuvo Research, a drug development company, has announced that the FDA has accepted the company's resubmission of its application to market Pennsaid in the US as a complete response to the FDA's December 28, 2006 approvable letter.
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The FDA has indicated that it intends to advise Nuvo of its decision regarding Pennsaid approvability by August 5, 2009 under the Prescription Drug User Fee Act.
Pennsaid, a topical non-steroidal anti-inflammatory drug, is currently marketed in Canada and several European countries to treat the pain and symptoms associated with osteoarthritis.
Pennsaid allows the active ingredient, diclofenac, to be delivered to a specific site via the surface of the skin and thus limits complications. The clinical trials of Pennsaid indicate that it is as effective as the maximum daily dose of comparable oral medication at relieving pain and stiffness associated with osteoarthritis of the knee, as well as improving overall well-being.
Henrich Guntermann, president and CEO of Nuvo Research, said: We are now less than six months away from the anticipated approval of Pennsaid in the US. We are extremely optimistic about Pennsaid’s potential for approval and are continuing discussions with potential US licensing partners.