plunged 25% Friday after getting a Food and Drug Administration approvable letter for its once-daily formulation of arthritis pain drug tramadol.
The Laval, Quebec, company said the product is approvable subject to the resolution of certain issues. The company plans to discuss the letter with the FDA as soon as possible and believes that it can address the issues raised in the letter without the need for additional data.
Potential outcomes with respect to resolution of the issues range from utilization of current data to the need to generate additional data.
"We plan to work closely with the FDA to resolve the outstanding issues and obtain final approval," said CEO James R. Howard-Tripp. "We will provide further information following discussions with the FDA and clarification of the path forward."
Shares fell $1.65 to $5.66.