The FDA has approved Cadence Pharmaceuticals' ($CADX) Ofirmev injection (acetaminophen) for the treatment of management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. The FDA has twice denied approval of the drug. In November 2009, the agency extended the approval deadline to review additional clinical pharmacology data; it was delayed again until manufacturing problems at a third-party facility were resolved. Ofirmev is Cadence's first approved drug. The company expects to begin marketing the drug in March 2011.
"IV acetaminophen is the unit market share leader among all injectable pain medications in Europe," says Cadence CEO Ted Schroeder in a release. "With our planned launch early in the first quarter of 2011, we believe that Ofirmev will fill a significant gap in the United States for the treatment of pain and fever in the hospital setting."
- check out Cadence's release
- read the Reuters report for more