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Atripla Approval History

FDA Approved: Yes (First approved July 12, 2006)
Brand name: Atripla
Generic name: efavirenz, emtricitabine and tenofovir disoproxil fumarate
Dosage form: Tablets
Company: Bristol-Myers Squibb Company / Gilead Sciences, Inc.
Treatment for: HIV Infection

Atripla is a once-daily single tablet regimen combining the non-nucleoside reverse transcriptase inhibitor Sustiva (efavirenz), and the nucleoside reverse transcriptase inhibitors Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate). Atripla is indicated as a stand-alone therapy or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults.

Development History and FDA Approval Process for Atripla

DateArticle
Jan 11, 2010Approval HIV/AIDS Update - Atripla label update reflects new efficacy, safety and resistance data in treatment experienced patients
Jul 12, 2006Approval Atripla Bristol-Myers Squibb Company / Gilead Sciences, Inc. - Treatment for HIV-1 Infection

Further information

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