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.