voluntarily withdrew a drug application filed with the Food and Drug Administration to market its Alzheimer's drug, memantine.
The company said it will refile the application to include new efficacy and safety data from a recent phase III study of the drug.
The "placebo-controlled, double-blind" phase III study found that in moderate-to-severe Alzheimer's patients, memantine, in combination with donepezil, improved patient cognition, daily function and overall status, when compared with donepezil treatment alone, the company said. Both drugs are used to fight dementia caused by Alzheimer's.
The refiling is expected to be completed by the end of the year. Forest also said it will correct certain structural and formatting deficiencies identified by the FDA in its previous application.
Shares of New York-based Forest Labs closed at $76.75 Friday on the
New York Stock Exchange