Andrx Gets FDA Approvable Letter for Fortamet
FORT LAUDERDALE, Fla. (Dow Jones)–Andrx Corp. received a Food and Drug Administration approvable letter for Fortamet, an extended-release drug to regulate blood sugar in diabetes patients, in 500- and 1,000-milligram tablets.
An approvable letter sets out the conditions a company must meet to obtain FDA marketing approval for a drug.
In a press release Thursday, Andrx said it expects to address the requirements of the letter by the end of the fourth quarter, and anticipates receiving FDA approval and launching Fortamet in the first half of 2004.
Fortamet, which is Andrx's second internally branded product, uses the company's drug-delivery technology to provide once-daily doses to help control blood sugar in patients with type 2 diabetes.
Andrx submitted an application in May to market the drug in Europe.
Company Web site: http://www.andrx.com