For the first time ever, the Food and Drug Administration has decided to approve the generic form of the blockbuster drug Wellbutrin XL. Wellbutrin is an extended release anti depressant used for major depression disorder. Research suggests that depression may be caused by an imbalance of brain chemicals called neurotransmitters. Wellbutrin works by balancing the levels of the brains neurotransmitters called dopamine and norepinephrine.
Anchen Pharmaceuticals Incorporated out of Irvine California was granted the license to produce the generic medication. The brand version produced last year by GlaxoSmithKline was the 21 highest selling medication on the market in the United States, recording over 1.3 billion dollars in sales.
Although it received approval for generic reproduction, it did not come without a fight from Biovail, a biotech company partnered with GlaxoSmithKline. Biovail whose stock has fallen since the announcement of generic reproduction, sued the FDA to in an attempt to stop it from approving a generic version of the Wellbutrin. The company claimed the agency had looked over safety issues surrounding a generic version of the drug. An FDA statement Friday said Anchen Pharmaceutical's application adequately addressed these issues.
According to Healthday, “Less-costly generic drugs are now used to fill more than 50 percent of all prescriptions, the FDA said. “Consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand-name drug and is its equal in dosage form, strength, and route of administration, quality, performance characteristics, and intended use," the agency statement added.”
