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DewDiligence

09/26/14 11:40 AM

#182194 RE: DewDiligence #177082

FDA approves GILD’s Vitekta (elvitegravir) and Tybost (cobicistat)—constituents of Stribild—as standalone entities:

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

This action has relatively little practical consequence insofar as Vitekta and Tybost figure to see little use as standalone entities. It was a fluke that the FDA approved Stribild before approving two of its constituent drugs.

Vitekta and Tybost are already approved in the EU under the same brand names.