TRENTON, N.J. (AP) - The U.S. Food and Drug Administration has rejected GlaxoSmithKline PLC's application to approve an experimental drug for nausea and vomiting, saying more data is needed.
The British drugmaker said Tuesday that it had received a "complete response letter" from the FDA regarding its application for casopitant. Glaxo applied to the FDA in May 2008 for approval to sell the drug for nausea and vomiting that occurs after surgery or is triggered by chemotherapy.
The FDA's Center for Drug Evaluation and Research issues complete response letters when staff have finished reviewing all the experimental and other data in a new drug application and there are outstanding questions or issues that bar approval of the product.
GlaxoSmithKline said in a statement that the company is reviewing the FDA's letter and will work with the agency to decide the next appropriate steps.
Company spokeswoman Lisa Behrens said the FDA is requiring specific, additional information in order to consider approval of casopitant.
Glaxo plans to sell the drug under the trade name Rezonic. It already sells a drug for nausea caused by chemotherapy and radiation therapy, Zofran, and tested Rezonic for its effectiveness in combination with both Zofran and a third drug, dexamethasone.
If approved, Rezonic would compete with a few similar drugs, including Whitehouse Station, Merck & Co.'s Emend, Tokyo-based Eisai Co. Ltd.'s Aloxi and New Jersey-based Par Pharmaceutical's Marinol.
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