FDA gives tentatitve approval for Galantamine
PRINCETON, N.J. The Food and Drug Administration has granted tentative approval to Ranbaxy Laboratories to manufacture and market Galantamine Hydrobromide tablets in 4, 8 and 12 mg.
Galantamine is used for the treatment of mild to moderate dementia in Alzheimer’s patients. According to Jim Meehan, vice president of sales and distribution for Ranbaxy Pharmaceuticals, which is a wholly owned subsidiary of Ranbaxy Laboratories, "We will launch the product upon final approval, which is anticipated on Dec. 14, 2008. At the time of launch, the product will be available immediately to all classes of trade."