Cadence Pharmaceuticals, Inc has resubmitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational product candidate, Ofirmev (acetaminophen) injection, for the treatment of pain and fever in adults and children.
The NDA for Ofirmeve was resubmitted on May 4, 2010. The US FDA will determine the type of resubmission (Class 1 or Class 2) and resulting review timeline (two months or six months, respectively) subsequent to this NDA submission.
On February 10, 2010, Cadence received a Complete Response letter from the US FDA which only indicated that the Ofirmev NDA could not be approved due to deficiencies observed during the US 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 met with the US FDA on April 16, 2010 to discuss the deficiencies outlined in the letter, at which time the agency did not request any new safety, efficacy, or stability studies. Based upon Cadence's discussions with the US FDA, Cadence has now resubmitted the NDA to move toward potential approval of Ofirmev.
Ofirmev is Cadence Pharmaceuticals' proprietary intravenous formulation of acetaminophen. Acetaminophen is the most widely used 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.
Cadence Pharma is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting.