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www.fdanews.com/articles/70791-biovail-s-generic-ultram-needs-more-studies-fda-says

Biovail's Generic Ultram Needs More Studies, FDA Says

April 6, 2005

Biovail might have to delay the launch of its Tramadol ER product by up to 18 months after learning that the FDA wants more clinical studies performed on the drug, an extended-release, once-daily version of Johnson & Johnson's painkiller Ultram (tramadol HCl).

The FDA issued Biovail an approvable letter for Tramadol ER in October 2004, requesting more data about the drug's safety and efficacy. The company submitted a response to the agency earlier this month with additional statistical analyses but no new clinical data. Upon preliminary review of Biovail's response, the FDA said more clinical studies will be needed before final marketing approval can be granted for Tramadol ER.

Biovail contends that its response was adequate, and the firm plans to meet with the FDA to discuss its options. In the meantime, the company said it will immediately launch a clinical program to address the agency's concerns. Biovail said the new data submission would be ready by late 2005 or early 2006, at which time the FDA would initiate a new six-month review period for the drug.