Tuesday, December 10, 2013

U.S. FDA panel to review Oralair for approval: documents

(Reuters) - An oral immunotherapy aimed at grass and pollen allergies has a benefit and safety profile that supports its approval, according to company documents posted on Monday by the U.S. Food and Drug Administration ahead of a meeting by outside experts to discuss the drug. Oralair, made by France's Stallergenes SA, would be the first such licensed therapy in the United States. It has been in use in Europe for several years. The documents were posted prior to a meeting on Wednesday of an FDA advisory committee meeting that will provide a recommendation on whether the drug merits U.S. approval.



via Health News Headlines - Yahoo! News http://news.yahoo.com/u-fda-panel-review-oralair-approval-documents-182717294--finance.html

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