FDA Accepts Nuvo's Resubmission For Pennsaid(R)
Thu, 02/19/2009 - 4:12am
Nuvo Research Inc., a Canadian drug development company focused on the research anddevelopment of drug products delivered to and through the skin using itstopical and transdermal drug delivery technologies, today announced that theU.S. Food and Drug Administration (FDA) has accepted Nuvo's resubmission ofits application for FDA approval to market Pennsaid in the U.S. as a completeresponse to the FDA's December 28, 2006 Approvable Letter. The FDA hasindicated that it intends to advise Nuvo of its decision regarding Pennsaidapprovability by August 5, 2009 (the "PDUFA Date") under the Prescription DrugUser Fee Act. Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), iscurrently marketed in Canada and several European countries to treat the painand symptoms associated with osteoarthritis. "We are now less than six months away from the anticipated approval ofPennsaid in the U.S.," said Dr. Henrich Guntermann, President and CEO of NuvoResearch. "We are extremely optimistic about Pennsaid's potential for approvaland are continuing discussions with potential U.S. licensing partners."