BIOVAIL SUES FDA OVER GENERIC WELLBUTRIN XL

Pharmacy Times, Volume 0, 0

Canadian drug maker Biovail Corp has filed suit against the FDA in an attempt to curb generic competitionfor its widely prescribed antidepressant Wellbutrin XL. The FDA has already granted tentativeapproval for a generic version of the drug to be marketed by Anchen Pharmaceuticals, but final clearancefor that product has been stalled by litigation between Biovail and Anchen.At least 3 other manufacturershave applications pending with the FDA for the marketing of a similar generic product.

Biovail has filed a citizen's petition with the FDA to delay approval of generic versions of WellbutrinXL, arguing that any abrupt approval of the sale of a generic version of the antidepressant wouldcause "irreparable" harm to the company. Lawyers for Biovail said the company is also seeking atemporary restraining order directing the FDA to resolve issues raised by the petition at least 1 weekbefore approving any generic versions of Wellbutrin XL.