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Exalgo FDA Approval History

FDA Approved: Yes (Discontinued) (First approved March 1, 2010)
Brand name: Exalgo
Generic name: hydromorphone
Dosage form: Extended Release Tablets
Company: Mallinckrodt Inc.
Treatment for: Pain

Marketing Status: Discontinued

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 timeline 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

Further information

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