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Exalgo Approval History

  • FDA approved: Yes (First approved March 1st, 2010)
  • Brand name: Exalgo
  • Generic name: hydromorphone
  • Dosage form: Extended Release Tablets
  • 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.

Development History and FDA Approval Process for Exalgo

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

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