positive results from Phase III trial announced 12/08; NDA filed 5/09; priority review granted 7/09 with PDUFA date of 11/13/09; PDUFA date extended to 2/2010; FDA denies drug citing deficiencies in its third-party manufacturing facility (2/10) and puts NDA on hold; no new studies needed with expected approval later in 2010; resubmission expected in next 30 days (4/10); resubmission sent to FDA 5/10; PDUFA date set 11/4/10
Brand Ofirmev (formerly known as Acetavance) Generic acetaminophen
Company name Cadence Pharmaceuticals, Baxter Product type Non-speciality
Therapeutic category CNS Key uses Pain management, treatment of acute pain and fever in adults and children
Other Uses N/A Drug Class analgesic
Dosage From IV Expected Approval 2010-Q4
FDA Filing 5/09 Last Update date May 24,2010
Link to news release