CIP-Tramadol ER approved for chronic pain

The FDA has approved Cipher Pharmaceuticals’ CIP-Tramadol ER, an extended-release tramadol product, for the treatment of moderate to moderately severe chronic pain in adults. Cipher is preparing for the commercial launch of CIP-Tramadol ER, pending the finalization of commercial manufacturing requirements. The timing of the launch will also be influenced by the outcome of the appeal filed by Purdue Pharma against Par Pharmaceutical, which relates to the Orange Book-listed patents for Ultram ER (tramadol HCl extended-release tablets, from PriCara), the reference product in Cipher’s New Drug Application (NDA). A decision in that case is not expected until late 2010.

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