Complete Response Letters
Cadence Pharmaceuticals: Ofirmev
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Feb 10, 2010
Ofirmev (acetaminophen) Injection, 10mg/mL.
CRL_NDA022450_20100210:p1:s12We have completed the review of your application, and have determined that we cannot approve this application in its present form.
CRL_NDA022450_20100210:p1:s16During a recent inspection of the Baxter Healthcare manufacturing facility in Cleveland, MS for this application, our investigator conveyed deficiencies to the representative of the facility.
CRL_NDA022450_20100210:p1:s19Satisfactory compliance with Current Good Manufacturing Practices for Drugs is required for all manufacturing and testing facilities listed in the NDA before this application may be approved.
CRL_NDA022450_20100210:p1:s208. Provide English translations of current approved foreign labeling not previously submitted.
CRL_NDA022450_20100210:p1:s44More Complete Response Letters
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