Abstral Approval History beta

  • FDA approved: Yes (First approved January 7th, 2011)
  • Brand name: Abstral
  • Generic name: fentanyl
  • Company: Orexo AB
  • Treatment for: Pain

Abstral (fentanyl) is a sublingual opioid analgesic indicated for the management of breakthrough pain in cancer patients.

FDA Approval History for Abstral

DateArticle
Jan 10, 2011Approval FDA Approval for Abstral (Fentanyl) Sublingual Tablets
Sep  7, 2010Update on the FDA review for Abstral
Jun 15, 2010Orexo confirms Abstral PDUFA date update
Oct  6, 2009Orexo confirms FDA acceptance of Abstral filing
Aug  6, 2009Abstral NDA submitted to the FDA for approval in the USA

See also...

Abstral (fentanyl) Consumer Information

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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