FDA Discusses Neuromed NDA Application For Exalgo

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 18 Nov 2009 - 0:00 PDT

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Covidien (NYSE: COV) announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate ExalgoTM (hydromorphone HCl extended release) tablets with staff from the United States Food and Drug Administration (FDA). Mallinckrodt Inc., a Covidien company, obtained the commercial rights to Exalgo in the United States from Neuromed Development Inc., a subsidiary of Neuromed Pharmaceuticals Ltd., in June 2009.

Neuromed is seeking FDA approval for Exalgo 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. In these discussions, the FDA staff indicated that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo under Section 505(b)(1) of the Food, Drug and Cosmetic Act of 1938, as amended (FDCA). The FDA had assigned a PDUFA date of November 22, 2009, to complete its review of the application.

Based on Neuromed's recent discussions with the FDA, Covidien is working closely with Neuromed on the appropriate next steps to be taken regarding the NDA. Possible next steps include amending the existing NDA, or potentially resubmitting the NDA under Section 505(b)(2) of the FDCA, which utilizes different criteria to determine the basis for approval of a new drug candidate.

Covidien's 2010 sales and operating margin guidance, provided on September 10, 2009, had not assumed any contribution from Exalgo.

Source
Covidien

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