Friday, medical devices and pharmaceuticals company Covidien Ltd. (COV) said the U.S. Food and Drug Administration has extended the review of its New Drug Application for Exalgo pain medication by three months. The FDA decided to extend the action date to gain time to review additional supplemental information, which was filed by Covidien after FDA's recent indication that it may not approve the drug.
FDA determined that the supplemental information on Exalgo tablets, or hydromorphone HCl extended-release tablets, is a major amendment to the application, and therefore decided to extend the action date until February 22, 2010.
Exalgo's proposed indication is once daily 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. Based on the number of prescriptions, Covidien is the largest supplier of controlled pain medications in the U.S.
Covidien, along with its drug developer Neuromed, provided the supplemental information following a discussion with the FDA on November 13th over the new drug application. During the discussion, FDA indicated that the application in its current form is not sufficient to form the basis of approval for Exalgo. The previous date for completion of the review was November 22nd.
After the discussion, Covidien revealed on November 16th that it planning to amend the existing application, or resubmit the application under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which utilizes different criteria to determine the basis for approval of a new drug candidate.
The U.S. rights to Exalgo were acquired from pain-medicine developer Neuromed Pharmaceuticals Ltd. by Mallinckrodt Inc., a subsidiary of Covidien, in June 2009. Under the agreement, Covidien is responsible for all commercialization activities for Exalgo in the U.S., including marketing, sales, and all post-approval FDA regulatory filings. Post acquisition, Neuromed is assisting Covidien to complete the clinical development and regulatory approval process.
Timothy Wright, president of Covidien's pharmaceuticals division said, "We are committed to providing patients with advanced pain medications and are optimistic that Exalgo will be approved. We will continue working with Neuromed and the Agency on securing approval for Exalgo."
COV is losing $0.18 or 0.40%, and is trading at $44.95 on a volume of one thousand shares on the New York Stock Exchange.
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