| Covidien announced that the U.S. FDA has set a new action date under the Prescription Drug User Fee Act for the review of the New Drug Application, or NDA, for Exalgo, or hydromorphone HCl extended-release, Tablets CII, of February 22, 2010. Neuromed Pharmaceuticals and Covidien recently provided the FDA with supplemental information, which the agency determined to be a major amendment to the NDA. As a result, the FDA has extended its action date by three months to allow more time to review the application. The proposed indication for Exalgo is once daily administration for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. :theflyonthewall.com |
