The NDA for Ofirmev was resubmitted on May 4, 2010. The FDA is expected to 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.
Earlier on February 10, 2010, Cadence Pharmaceuticals had received a complete response letter from the FDA which only 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.
Reportedly, the complete response letter did not cite any safety or efficacy issues or require that any additional studies be conducted prior to approval.
Cadence Pharmaceuticals met with the 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 FDA, Cadence has now resubmitted the NDA to move toward potential approval of Ofirmev.