Exalgo Approval History

  • FDA approved: Yes (First approved March 1st, 2010)
  • Brand name: Exalgo
  • Generic name: hydromorphone
  • Company: Covidien
  • Treatment for: Pain

Exalgo (hydromorphone) is a once-a-day extended release opioid formulation 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.

FDA Approval History for Exalgo

DateArticle
Aug 27, 2012Approval FDA Approves Mallinckrodt's Exalgo (hydromorphone HCl) Extended-Release Tablets 32 mg (CII) for Opioid-Tolerant Patients with Moderate-to-Severe Chronic Pain
Mar  2, 2010Approval FDA Approves Exaglo (hydromorphone HCl) Extended-Release Tablets
Feb 17, 2010CombinatoRx Announces Extension of Exalgo Extended-Release Tablets PDUFA Date to March 1, 2010
Nov 16, 2009Neuromed Receives FDA Feedback on New Drug Application for Exalgo Extended-Release Tablets
Sep 23, 2009FDA Advisory Committee Hears Presentations and Public Comment on Exalgo Extended-Release Tablets

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)