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.
“We are pleased to complete the submission of this NDA,” said Valeant’s CEO, Timothy Tyson said. “The two safety studies conducted in response to the FDA’s approvable letter were successfully completed over the past several months and the results are in line with our expectations. Zelapar is an important pipeline candidate for Valeant, which we expect to make available to the market by mid-2005.”
Valeant expects the FDA to complete its review within six months from the date of submission.