Nuvo Research Inc, a Canadian drug development company focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies, announced that the US Food and Drug Administration (FDA) has accepted Nuvo's resubmission of its application for FDA approval to market Pennsaid in the US as a complete response to the FDA's December 28, 2006 Approvable Letter.
The FDA has indicated that it intends to advise Nuvo of its decision regarding Pennsaid approvability by August 5, 2009 (the PDUFA Date) under the Prescription Drug User Fee Act.
Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is currently marketed in Canada and several European countries to treat the pain and symptoms associated with osteoarthritis. "We are now less than six months away from the anticipated approval of Pennsaid in the U.S.," said Dr Henrich Guntermann, president and CEO of Nuvo Research. "We are extremely optimistic about Pennsaid's potential for approval and are continuing discussions with potential US licensing partners."
Pennsaid is a topical non-steroidal anti-inflammatory drug used for the treatment of osteoarthritis.
Nuvo is focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies.