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News Breaks
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November 13, 2009
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| 07:33 EDT |  | CADX |
| theflyonthewall.com: | FDA extends PDUFA goal date for intravenous acetaminophen | | Cadence Pharmaceuticals announced that the FDA has extended the Prescription Drug User Fee Act goal date for its Priority Review of the New Drug Application for intravenous acetaminophen by three months. The extended PDUFA goal date is February 12, 2010. The FDA designated one of Cadence's submissions to the NDA, which contained additional clinical pharmacology data requested by the agency during the review process, as a major amendment. :theflyonthewall.com |
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February 6, 2012
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| 17:03 EDT | | CADX |
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