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news.Nuvo Research, a Canadian drug development company, has announced that it has successfully completed all of the studies that will support the company's resubmission of its Pennsaid application to the FDA.
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Nuvo is in the process of finalizing its resubmission for Pennsaid approval, which it expects to file with the FDA within the next 60 days. Upon acceptance of the filing, the FDA is expected to provide Nuvo with a date under the Prescription Drug User Fee Act (the PDUFA date), by which the FDA will advise Nuvo of its decision respecting Pennsaid’s approvability. Nuvo anticipates the PDUFA date will be six months after it files its Pennsaid resubmission.
Nuvo’s resubmission is a complete response amendment to an approvable letter for Pennsaid received from the FDA in December 2006. Nuvo believes that the completed studies support the safety of the Pennsaid bottle and provide the specific information identified by the FDA as needed to support the safe use of Pennsaid with other topical products.
In addition, Nuvo has completed two preclinical repeat dose dermal toxicology studies in animals, both of which support Pennsaid’s safety.
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.
Henrich Guntermann, president and CEO of Nuvo, said: We are confident that the results and information gathered from these studies will provide the FDA with the data it requires to give Nuvo final, unconditional approval to market Pennsaid in the US.