Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that, based on feedback received during a meeting with the U.S. Food and Drug Administration (FDA) on April 16, 2010, it plans to re-submit a New Drug Application (NDA) for its investigational product candidate, OFIRMEV™ (acetaminophen) injection, within the next 30 days.
The April 16 meeting was a Type A meeting held among the FDA, Cadence, and its third party manufacturer to discuss the deficiencies outlined in the Complete Response letter related to an inspection of the facility used to manufacture OFIRMEV.
"We believe that last week's meeting with FDA was an important step forward to address the observations from the FDA's inspection of our third party manufacturer's facility and move toward potential approval of OFIRMEV," stated Ted Schroeder, President and CEO. "Based upon our discussions with the agency, we believe that it is appropriate to promptly resubmit the NDA for OFIRMEV and intend do so within the next 30 days."
At the meeting, the FDA did not request any additional information related to the NDA, including any new stability studies. The agency will determine the type of resubmission (Class 1 or Class 2) and resulting review timeline (two months or six months, respectively) after the NDA is resubmitted. Cadence will continue to work with its third party manufacturer to ensure that the observations from the FDA's inspection of the manufacturing facility for OFIRMEV are resolved in a timely manner.
SOURCE Cadence Pharmaceuticals, Inc.