Abstral FDA Approval History
Last updated by Judith Stewart, BPharm on June 9, 2020.
FDA Approved: Yes (Discontinued) (First approved January 7, 2011)
Brand name: Abstral
Generic name: fentanyl
Dosage form: Sublingual Tablets
Company: Orexo AB
Treatment for: Pain
Marketing Status: Discontinued
Abstral (fentanyl) is a sublingual opioid analgesic indicated for the management of breakthrough pain in cancer patients.
Development timeline for Abstral
| Date | Article |
|---|---|
| Jan 10, 2011 | Approval FDA Approval for Abstral (Fentanyl) Sublingual Tablets |
| Sep 7, 2010 | Update on the FDA review for Abstral |
| Jun 15, 2010 | Orexo confirms Abstral PDUFA date update |
| Oct 6, 2009 | Orexo confirms FDA acceptance of Abstral filing |
| Aug 6, 2009 | Abstral NDA submitted to the FDA for approval in the USA |
Further information
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