Cadence Says FDA Approves Ofirmev
From Associated Press (November 2, 2010)
SAN DIEGO -- Drug maker Cadence Pharmaceuticals Inc. said Tuesday the U.S. Food and Drug Administration granted marketing approval for its injectable pain and fever relief drug.
Ofirmev is an intravenous formulation of acetaminophen, the same drug found in Tylenol. Ofirmev is for management of mild to moderate pain and reducing fever. It will also be marketed as an additional component in treatments for moderate to severe pain, along with opioids.
In February, the FDA held off approving Ofirmev because of manufacturing concerns. Cadence resubmitted its application for the drug in May.
Under a licensing agreement, Cadence will make a $15 million payment tied to U.S. approval of the drug.
The company plans to begin commercial sales of the drug in the first quarter of 2011.
Cadence shares fell 44 cents, or 4.9 percent, to $8.53 in after-hours trading.
Posted: November 2010