SECOND APPROVABLE LETTER GRANTED FOR VALEANT'S ZELAPAR
The FDA has issued Valeant Pharmaceuticals a second "approvable" letter requesting additional data on the company's experimental Parkinson's disease drug Zelapar.
Valeant plans to meet with the agency as soon as possible to discuss the letter, which "requests additional clarification on specific issues previously addressed by Valeant," the company said recently.
Zelapar (selegiline), which is under review as an adjunct treatment to levodopa/carbidopa in Parkinson's patients, was first deemed approvable in February 2003. The FDA requested two additional safety studies on the drug, both of which Valeant submitted to the FDA in January 2005.