Pennsaid gets FDA approvable letter

Canadian Pharmaceutical company Nuvo Research says that its osteoarthritis treatment Pennsaid (1.5% diclofenac sodium solution) is the subject of an approvable letter issued by the US Food and Drug Administration. The company added that it plans to meet with the FDA early this year to discuss its requirements.

The Mississauga-headquartered firm said that the FDA's acceptance of the Pennsaid New Drug Application in July last year (Marketletter July 24, 2006) was as a result of it addressing safety and efficacy concerns raised by the agency in a non-approvable letter issued in 2002. The company added that it had conducted a 12-week Phase III trial that met all of its primary endpoints, including the demonstration of comparable efficacy to oral diclofenac.