FDA Issues Complete Response Letter To Cadence’s Acetaminophen

Ofirmev is Cadence’s proprietary intravenous formulation of Acetaminophen. Acetaminophen has been used as a medication for the treatment of pain and fever in the US, and is available in more than 600 combination and single-ingredient prescription and over-the-counter products.

In the complete response letter, the FDA indicated that deficiencies were observed during the facility inspection of Cadence’s third party manufacturer, which was completed on February 5, 2010. The FDA did not cite any safety or efficacy issues, nor did it request any additional studies to be conducted prior to approval.

The company said that it’s third party manufacturer intends to respond promptly to the observations, and Cadence plans to request a meeting with the FDA to ensure that the deficiencies have been adequately addressed to meet the requirements for NDA approval.

The FDA has also informed the company that Ofirmev has been determined to be an acceptable trade name for IV Acetaminophen. The company is very pleased with label discussions to date and continues to seek approval of Ofirmev for the management of pain and the reduction of fever in adults and children.

Ted Schroeder, president and CEO of Cadence, said: “Cadence is committed to making this important new medicine available to patients and will continue to work closely with the FDA and our third party manufacturer to ensure that the observations are addressed as quickly as possible.”