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news.FDA has classified Cadence Pharmaceuticals' (Cadence) Ofirmev (acetaminophen) injection new drug application (NDA) resubmission as a complete Class 2 response to the February 10, 2010 action letter and assigned a new Prescription Drug User Fee Act (PDUFA) action date of November 4, 2010.
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Cadence said that on February 10, 2010, it received a complete response letter from the FDA which indicated that the Ofirmev NDA could not be approved due to deficiencies observed during the FDA’s facility inspection of Cadence’s third party manufacturer. The complete response letter did not cite any safety or efficacy issues or require that any additional studies be conducted prior to approval.
Cadence stated that it met with the FDA on April 16, 2010 to discuss the deficiencies outlined in the complete response letter, at which time the agency did not request any new safety, efficacy, or stability studies. Based upon discussions with the FDA, Cadence resubmitted the NDA on May 4, 2010. The FDA has not yet indicated whether it plans to re-inspect the facility used to manufacture Ofirmev.
Ted Schroeder, president and CEO of Cadence, said: “If approved, Ofirmev is expected to be the only intravenous (IV) non-opioid, non-NSAID pain medication available in the US, and we are committed to making this important therapeutic option available to patients as soon as possible.
“We will continue to work closely with the FDA through this final stage of the review process and maintain our commercial readiness activities for potential approval at any time up to the PDUFA action date.”