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Food & Drug Law Weekly

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Bristol-Myers Squibb



Long-term data provides guidance on use of Sustiva in HIV treatment



September 24th, 2004

Bristol-Myers Squibb Company (NYSE:BMY) announced that SUSTIVA (efavirenz) has received approval from the U.S. Food and Drug Administration (FDA) to include new long-term virologic and clinical data from BMS Study 006 in its prescribing information.

The new data demonstrate the long-term durability of virologic response in people living with HIV-1 who are naive to protease inhibitors, lamivudine (3TC) and non-nucleoside reverse transcriptase inhibitors (NNRTI) through more than 3 years of treatment on a combination regimen containing SUSTIVA.

"The new data from Study 006 provide valuable information to healthcare professionals supporting first-line...


Source: Food & Drug Law Weekly (2004-09-24)

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