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FDA Rejects Two Gilead Sciences Inc's HIV Drugs As Standalone Products-Reuters


Monday, 29 Apr 2013 10:32am EDT 

Reuters reported that Gilead Sciences Inc said that U.S. health officials rejected two of its HIV drugs as standalone therapies, citing deficiencies in documentation and validation of certain quality testing procedures. Gilead said it is working with the U.S. Food and Drug Administration to address the questions raised in the rejection letter in order to prove the application forward. The Company is seeking approval for its drug elvitegravir for people with HIV, the virus that causes AIDS, who have already been treated with other products. The drug blocks the enzyme integrase which is needed for the HIV virus to replicate. 

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22 Jul 2014