VALEANT SUBMITS COMPLETE RESPONSE TO FDA APPROVABLE LETTER FOR ZELAPAR

Valeant Pharmaceuticals International has recently submitted a complete response to an approvable letter from the FDA for Zelapar following the successful completion of two safety studies required for its approval.

Valeant expects the FDA to complete its review within six months from the date of submission. Zelapar (selegiline hydrochloride) is a late-stage candidate under review by the FDA as an oral tablet using the patented Zydis fast-dissolving technology and is being developed as an adjunct treatment in the management of patients with Parkinson's disease being treated with levodopa/carbidopa.