Biovail Corporation confirmed that the US Food and Drug Administration (FDA) assigned a Class 2 certification to the company's response submitted on October 23, 2007, to the FDA Action Letter for Biovail's compound BVF-033, a novel salt formulation of bupropion.
A Class 2 response is subject to a six-month review period by the FDA. A PDUFA date of April 23, 2008, has been set for receipt of the FDA's decision.
"Biovail is surprised and disappointed by the FDA's decision with respect to the status of our Complete Response," said Dr. Douglas Squires, chief executive officer, Biovail. "Biovail remains fully committed to securing the approval of BVF-033."
Biovail continues to believe the data package submitted to the FDA is sufficient to support the approval of BVF-033.
Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialisation of pharmaceutical products utilizing advanced drug-delivery technologies.