GlaxoSmithKline has received an approvable letter from the U.S. Food and Drug Administration (FDA) for the antidepressant Wellbutrin XL (bupropion hydrochloride extended-release tablets), which is under review for the treatment of major depressive disorder in patients aged 18 and older. GlaxoSmithKline is working with the FDA to clarify and resolve outstanding issues.
"The approvable letter involves resolution of routine matters and consequently we remain on track for approval of Wellbutrin XL during the second half of 2003. We believe that this product will provide an important new treatment option for adults with depression," said Stan Hull, Senior Vice President, GlaxoSmithKline.
GlaxoSmithKline licensed the once-daily formulation of bupropion hydrochloride from Biovail Corporation in October 2001.