FDA delays release of ProStrakan's Sancuso
The US Food and Drug Administration has postponed the filing of a New Drug Application for the Scotland-based ProStrakan Group's Sancusco novel patch for the treatment of chemotherapy-induced nausea and vomiting.
The decision was made under the Prescription Drug User Fee Act and ProStrakan says the FDA's move is a result of resourcing issues within the agency.
The Action Date has been put back by approximately six weeks from early May to mid-June. ProStrakan still intends to have Sancusco on the US market by the second half of 2008.
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