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Biopharmaceutical company Bristol-Myers Squibb Company (NYSE:BMY) reported on Friday that it has received US Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) for SUSTIVA (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.
This study found a link between taking Sustiva and low vitamin D, while taking Viread or Norvir was linked to higher vitamin D levels.
The development of Atripla resulted from what the FDA called an unprecedented collaboration between BMS, the manufacturer of Sustiva, and Gilead, the manufacturer of Emtriva and Viread as well as Truvada, a fixed-dose combination of Emtriva and Viread.
The development of Atripla resulted from what the FDA called an unprecedented collaboration between BMS, manufacturer of Sustiva, and Gilead, manufacturer of Emtriva and Viread as well as Truvada, a fixed-dose combination of Emtriva and Viread.
Though there are no adequate, well-controlled studies in pregnant women, Sustiva should be used during the first trimester of pregnancy only if the potential benefit justifies the potential risk to the fetus, such as in pregnant women without other therapeutic options," Dr.
Sustiva + Epivir + (Zerit or Viread or Retrovir), or
In another study (known as the 2NN study because it compared and combined 2 non-nucs, Sustiva and Viramune), the regimens containing either Sustiva or Viramune were similar in their ability to control the virus, but they had different side effects.
With this acquisition, Bristol-Myers Squibb gains several important in-line products, including Sustiva [TM] (efavirenz), the leading non-nucleoside reverse transcriptase inhibitor for the treatment of HIV/AIDS; Coumadin [R] (warfarin sodium tablets, USP), a widely used oral blood anticoagulant; and Cardiolite [R], a leading cardiovascular medical imaging agent.
based DuPont's best-selling drug last year was Sustiva, which had sales of $386 million and is a widely used part of the powerful combination therapy for treating AIDS.
HIV Drugs 1999 Nonnucleoside Nucleoside Reverse Reverse Transcriptase Transcriptase Inhibitors Inhibitors (NNRTI) (NRTI) Rescriptor Combivir (delavirdine mesylate) (lamivudine/zidovudine) Viramune Epivir (nevirapine) (lamivudine) Sustiva Retrovir (efavirenz; DMP-266) (zidovudine; AZT; ZDV) Zerit (stavudine; d4T) Hivid (zalcitabine; ddC) Videx (didanosine; ddl) Ziagan (abacavir; 1592) Nucleotide Analogue Protease Inhibitors (PI) (*)Preveon Crixivan (adefovir dipivoxil; PMEA) (indinavir) Norvir (ritonavir) Fortovase (saquinavir) Viracept (nelfinavir mesylate) (*) Agenerase[TM] (amprenavir; 141W94, VX-478)
Data presented recently show that anti-HIV therapy including DuPont Pharmaceuticals' once-daily Sustiva (efavirenz) instead of the protease inhibitor, Crixivan (indinavir), achieves viral suppression in a greater percentage of patients than combinations including a protease inhibitor, and maintains suppression as well as combinations including the protease inhibitor.
As a whole, the combined market share of STRs will be affected by key patent expiries, such as those of BMS' Sustiva, a key component of Atripla.