Wednesday, Cadence Pharmaceuticals Inc. (CADX) announced that the New Drug Application for its investigational pain reliever Ofirmev injection, formerly known as Acetavance, was resubmitted to the U.S. Food and Drug Administration on May 4.
The FDA will determine the type of resubmission as Class 1 or Class 2, and based on the type, the review timeline might take two months or six months, respectively.
Cadence acquired the exclusive rights to Ofirmev injection in the United States and Canada in 2006 from Bristol-Myers Squibb Co. (BMY), which markets the product as Perfalgan in Europe and other parts of the world.
Ofirmev is an intravenous formulation of acetaminophen. Acetaminophen is the most widely used medication for the treatment of pain and fever in the United States and is available in more than 600 combination and single-ingredient prescription and over-the-counter products.
Intravenous acetaminophen is approved in approximately 80 countries, including major markets in Europe, where it is the market leader among all injectable analgesics.
Cadence initially submitted its New Drug Application for Ofirmev injection last May and was granted a priority review with the FDA decision date of November 13, 2009. However, the regulatory agency was unable to decide on Ofirmev within the deadline as it needed more time to review the additional pharmacology data submitted by the company, and extended the decision date to February 2010.
On February 11, 2010, the FDA issued a complete response letter for Ofirmev due to deficiencies at a facility used to manufacture the drug. The facility is operated by Cadence's third party manufacturer. However, the FDA did not cite any safety or efficacy issues, nor did it request any additional studies.
Cadence met with the FDA on April 16 to discuss the deficiencies outlined in the Complete Response Letter for Ofirmev and based on feedback received during the meeting, has resubmitted the NDA.
If approved, Ofirmev would become the first new intravenous analgesic approved in the United States in more than 20 years and the only approved intravenous agent for the treatment of fever in the United States.
CADX has thus far hit a 52-week low of 8.25 and 52-week high of $12.68. The stock closed Tuesday's trade at $10.04 on a volume of 361 thousand shares.
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