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Generic Wellbutrin XL Clears FDA Hurdle
August 6, 2013
HAYWARD, Calif. November 28, 2008 – IMPAX Laboratories, Inc. announced that the U.S. Food and Drug Administration (FDA) granted final approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Wellbutrin® XL 150 mg Extended-release Tablets on Wednesday, November 26, 2008. GlaxoSmithKline markets Wellbutrin® XL for the management of depression. IMPAX’s Global Pharmaceuticals division launched the product immediately following approval. According to Wolters Kluwer Health, U.S. sales of Wellbutrin® XL 150 mg tablets were approximately $950 million in the 12 months ended September 2008.
Wellbutrin is a trade name of the drug bupropion, which works by slowing the absorption of dopamine and norepinephrine in the synapse between nerve cells.
Source: Impax Laboratories
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