Biovail Sues FDA, Seeks Enforcement of Bioequivalence Criteria

Mississauga, ON (Aug. 24)-Biovail Corporation (www.biovail.com) is demanding that the US Food and Drug Administration enforce the “proper criteria” for determining bioequivalence of extended-release generic versions of bupropion products, including its “Wellbutrin XL” antidepressant. The company has filed suit against the agency referring to Biovail’s December 2005 Citizen Petition, which documents the company’s position on these criteria and the requirements that the labeling of a bioequivalent product be “substantially identical” to that of the approved brand-name product.

The company is seeking a temporary restraining order and a preliminary injunction directing FDA to resolve the issues set forth in the Citizen Petition at least one week before the agency’s supposed approval of a Wellbutrin XL generic product. The action is meant to ensure Biovail seeks “judicial review, if appropriate, of any FDA decision that does not incorporate Biovail’s stated approval criteria.”

The company claims the bioequivalence and labeling requirements stated in its Citizen Petition would protect the public against the potentially harmful effects of generic versions that were not truly bioequivalent or misleadingly labeled.