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Ofirmev Approval History

FDA Approved: Yes (First approved November 2, 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

Further information

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