FDA rejects two Gilead HIV drugs as standalone products

By Toni Clarke WASHINGTON (Reuters) – Gilead Sciences Inc said on Monday that U.S. health 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 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. …
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