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FDA rejects plans for nausea drug


An application by pharmaceutical giant GlaxoSmithKline to market an experimental drug for nausea and vomiting has been rejected.

The Food and Drug Administration in the US said more data about the drug was needed before it could approve its production.

The British drugmaker 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.

But Glaxo has received a “complete response letter” from the FDA regarding its application for casopitant and explaining its decision to deny approval.

The company said it will now review the points raised by the FDA’s Center for Drug Evaluation and Research and will work with the agency to decide the next appropriate steps.

Company spokeswoman Lisa Behrens said the FDA has requested specific, additional information in order to consider approval of casopitant.

If it does get approval, Glaxo would sell the drug under the trade name Rezonic, in addition to its Zofran drug, which is also used for nausea caused by chemotherapy and radiation therapy.

Tests studied Rezonic’s effectiveness in combination with both Zofran and a third drug, dexamethasone.

Copyright Press Association 2009

Food and Drug Administration

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