Biovail sues FDA over generic Wellbutrin bioequivalence

By Elaine Rigoli

Tampa, Fla., Aug. 24 - Biovail Corp. has filed suit against the Food and Drug Administration in the U.S. District Court for the District of Columbia over its Citizen Petition filed with the FDA on Dec. 20, 2005.

That Citizen Petition addressed Biovail's position for proper criteria to be employed by the FDA when determining bioequivalence for extended-release generic versions of bupropion products, and particularly those that reference Wellbutrin XL.

The Citizen Petition also addresses the requirement that the labeling for a bioequivalent product be substantially identical to that of the approved branded product, according to a company news release.

Biovail said it seeks a temporary restraining order and a preliminary injunction directing the FDA to resolve the issues raised by Biovail's Citizen Petition at least one week prior to the FDA's purported approval of any generic versions of Wellbutrin XL.

This will ensure that Biovail may seek judicial review, if appropriate, of any FDA decision that does not incorporate Biovail's stated approval criteria as set forth in its Citizen Petition.

Biovail said its Citizen Petition is intended to protect the public against the potentially harmful effects of generic versions of Wellbutrin XL that may not, in fact, be bioequivalent to Biovail's branded product, or that may be misleadingly labeled.

Biovail is a specialty pharmaceutical company based in Toronto.

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