FDA Wants Clarity From Valeant

Valeant Pharmaceuticals International (VRX) said Tuesday that it received conditional approval from the Food and Drug Administration to sell a new treatment for Parkinson's disease.

Put another way, before regulators will allow the drug to be sold, they want some type of further information.

The FDA is seeking "additional clarification on specific issues previously addressed by Valeant," the company said. "Valeant plans to meet with the FDA, promptly as they have requested, to discuss and resolve these matters."

Valeant's stock slipped as the company declined to identify the conditions set by the FDA in order for the agency to approve the drug, Zelapar. Valeant's shares fell 56 cents, or 2.8%, to $19.46.

This is the second time that the FDA has granted conditional approval for Zelapar, which is designed to work with other drugs in treating the progressive neurological disorder. In February 2003, the FDA's conditions included more safety trials when the drug was being developed by a British company called Amarin. Valeant acquired Amarin's U.S. unit last year in a deal that included the rights to Zelapar.

The drug was first submitted to the FDA in April 2002. Valeant completed the safety studies, and it resubmitted the Zelapar application in January 2005. At that time, Valeant predicted that Zelapar could reach the U.S. market by the middle of this year.

Zelapar is a faster-acting version of an existing drug, selegiline. Valeant is using a technology that allows the drug to dissolve in seconds and be absorbed in the mouth. Patients don't need to swallow or use liquid.

The delay in approving Zelapar could be related to the FDA's concerns that taking the drug with certain foods may elevate blood pressure, says Sagient Research Systems of San Diego. The firm, whose BioMedTracker report analyzes biotech issues, says selegiline tablets contain a warning about certain foods. The National Institutes of Health says such foods include liver, salami, sauerkraut, fish, poultry, yogurt, beer, red wine, avocados, bananas, figs and raisins.