Skip to Content

Ofirmev Approval History

  • FDA approved: Yes (First approved November 2nd, 2010)
  • Brand name: Ofirmev
  • Generic name: acetaminophen
  • Dosage form: Intravenous Injection
  • Previous name: Acetavance
  • Company: Cadence Pharmaceuticals, Inc.
  • Treatment for: Pain, Fever

Ofirmev (acetaminophen) is an intravenous analgesic product for the treatment of acute pain and fever in adults and children.

Development History and FDA Approval Process for Ofirmev

DateArticle
Nov  3, 2010Approval Cadence Pharmaceuticals Announces FDA Approval of Ofirmev (acetaminophen) injection for the Management of Pain and Fever
May 17, 2010Cadence Pharmaceuticals Announces Ofirmev NDA Action Date of November 4, 2010
May  5, 2010Cadence Pharmaceuticals Resubmits New Drug Application for Ofirmev
Apr 19, 2010Cadence Pharmaceuticals Announces Plan to Resubmit NDA for Ofirmev
Feb 11, 2010Cadence Pharmaceuticals Receives Complete Response Letter from FDA for Intravenous Acetaminophen NDA
Nov 13, 2009Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months
Jul 15, 2009Cadence Pharmaceuticals Announces Priority Review and Acceptance of NDA Submission for Acetavance for Treatment of Acute Pain and Fever
May 13, 2009Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever

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