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May 18, 2010
Share ThisCadence Pharmaceuticals Inc. (CADX) announced recently that the US Food and Drug Administration (FDA) will decide on its intravenous painkiller Ofirmev (acetaminophen) by November 4, 2010 (target date).
In February 2010, the US agency issued a complete response letter (CRL) to the company in response to the New Drug Application (NDA) filed for the approval of Ofirmev. The agency indicated in the letter that deficiencies were found at Cadence's third party manufacturing facility during the FDA's facility inspection. The FDA did not ask for any additional information related to the NDA. Furthermore, the agency did not ask Cadence to conduct any additional studies.
Cadence re-submitted the application on May 4, 2010, after meeting the US regulatory body and its third party manufacturer regarding the shortcomings highlighted in the CRL. The meeting, classified as Type A, is usually reserved for dispute resolutions, discussing clinical holds and special protocol assessment (SPA) following the receipt of the FDA's assessment letter.
The response of Cadence to the CRL was classified as a Class 2 response, which indicates a review period of six months. A decision from the US agency on Ofirmev will be out by November 4, 2010. However, the US regulatory authority has not yet indicated whether it plans to re-inspect the manufacturing facility of Ofirmev.
Ofirmev is Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen. Acetaminophen is the most prevalent therapy for treating pain and fever in the US. It is available in more than 600 combination and single-ingredient prescription and over-the-counter products.
The exclusive rights to Ofirmev in the US and Canada were acquired by Cadence in 2006 from Bristol-Myers Squibb (BMY) in 2006. The drug is marketed by Bristol-Myers as Perfalgan in Europe and other parts of the world. Intravenous acetaminophen is approved in approximately 80 countries globally, including major European markets, where it is the market leader among injectable analgesics.
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