Cipher Pharmaceuticals (DND.TO) Receives FDA Response to CIP-TRAMADOL ER Appeal
2/1/2008 3:18:00 PM
MISSISSAUGA, ON, Feb. 1 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND)
today announced that it has received a written response from the U.S. Food and
Drug Administration (FDA) regarding its appeal of the Agency's Approvable
Letter for CIP-TRAMADOL ER, Cipher's extended-release formulation of tramadol.
In the response, the Acting Director of the Office of Drug Evaluation II,
Center for Drug Evaluation and Research supported the Division's approvable