Cadence Re-Files FDA Application

5/5/10

Cadence Pharmaceuticals (NASDAQ: CADX), the San Diego-based developer of a pain reliever for use in hospitals, said today it has re-submitted its new drug application for the IV form of acetaminophen (Ofirmev) to the FDA. The company’s earlier application was delayed on February 10, when the FDA said it found deficiencies on an inspection of a third-party manufacturer. Cadence said it met with the FDA on April 16 to discuss the deficiencies found in the letter, and the agency didn’t require any new studies.

By posting a comment, you agree to our terms and conditions.