Covidien has reported that the FDA has set a new action date, under the Prescription Drug User Fee Act for the review of the New Drug Application (NDA) for Exalgo (hydromorphone HCl extended-release) tablets (CII), (Exalgo) of February 22, 2010.
Neuromed Pharmaceuticals and Covidien has 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.
Timothy Wright, president of pharmaceuticals at Covidien, 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.”
The US rights to Exalgo were acquired from Neuromed by Mallinckrodt, a Covidien company, in June 2009. Under the agreement, Covidien is responsible for all commercialisation activities for Exalgo in the US, including marketing, sales and all post-approval FDA regulatory filings. Neuromed will continue to work with Covidien to complete the clinical development and regulatory approval process.