FDAnews Drug Daily Bulletin

FDA Granted Approval for 32-mg Exalgo Tablets

Aug. 28, 2012
Zalicus announced the the FDA has granted approval for the supplemental new drug application filed by Mallinckrodt, a subsidiary of Covidien, for the 32-mg dose strength of Exalgo extended-release tablets, for the management of moderate to severe pain in opioid-tolerant patients requiring continuous opioid analgesia for an extended period of time.