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Latest Tramadol News |
Cipher Pharmaceuticals Inc. (TSX: DND:74.40, -0.66, -0.87%) today announced that a revised New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, its extended-release formulation of tramadol. In May 2007, the Company received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER. Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R: 65.60, -2.63, -3.85%) ER. After considering feedback from the FDA appeal process and the results of the additional statistical sensitivity analysis of existing data suggested by the FDA, Cipher and its advisors concluded that submitting the revised NDA provided the most expeditious path to final regulatory approval. see source article ... |
Cipher Submits Revised NDA for CIP-Tramadol ER The company's revised new drug application (NDA) includes data from additional pharmacokinetic studies conducted by the company comparing CIP-Tramadol ER to Ultram ER. Subject to FDA acceptance for filing, the company expects the review to be completed by October 2008. After considering feedback from the FDA appeal process and the results of the additional statistical sensitivity analysis of existing data suggested by the FDA, the company and its advisors concluded that submitting the revised NDA provided the most expeditious path to final regulatory approval. see source article ... |
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