BIOVAIL SUES FDA OVER GENERIC WELLBUTRIN XL

OCTOBER 01, 2006

Canadian drug maker Biovail Corp has filed suit against the FDA in an attempt to curb generic competition for its widely prescribed antidepressant Wellbutrin XL. The FDA has already granted tentative approval for a generic version of the drug to be marketed by Anchen Pharmaceuticals, but final clearance for that product has been stalled by litigation between Biovail and Anchen.At least 3 other manufacturers have 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 Wellbutrin XL, arguing that any abrupt approval of the sale of a generic version of the antidepressant would cause "irreparable" harm to the company. Lawyers for Biovail said the company is also seeking a temporary restraining order directing the FDA to resolve issues raised by the petition at least 1 week before approving any generic versions of Wellbutrin XL.




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