Biovail Confirms FDA Class 2 Status for BVF-033 Submission

The FDA has classified Biovail’s Oct. 23 response to the agency’s action letter for BVF-033, its novel salt formulation of bupropion, as Class 2.

A Class 2 response is subject to a six-month review period by the FDA. A Prescription Drug User Fee Act date of April 23, 2008, has been set for receipt of the agency’s decision.

Biovail said it was surprised by the decision, believing the data package submitted to the FDA was sufficient to support the approval of BVF-033.