Cipher Pharmaceuticals Inc (Cipher) has received tentative approval from the US FDA for Cip-Fenofibrate, the Company's novel formulation of the active ingredient fenofibrate, which is used in the treatment of hyperlipidemia. Final approval is subject to successful resolution of the Company's ongoing patent litigation, company said in a release.
"This marks another important milestone for Cipher and strongly validates our drug development strategy," said Larry Andrews, president of Cipher. "Reaching this milestone just three years after submitting our investigational new drug application clearly demonstrates our ability to rapidly develop unique formulations of currently marketed drugs using advanced drug delivery technologies," he added.
Cipher received an approvable letter from the FDA in January 2004 and was granted tentative approval after satisfying the requirements outlined in the letter. The Company now awaits final FDA approval, which is subject to successful resolution of its ongoing patent litigation. Under the provisions of the Hatch-Waxman Act, the litigation can delay final FDA approval by up to 30 months (ending March 2006), the release said.
Pending a successful judgment and final FDA approval, Reliant Pharmaceuticals Inc (Reliant) will market the product. Reliant has exclusive product supply rights in Canada, Mexico, and the United States, including its territories and possessions.