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  -- Formulation Marks The First One Capsule, Once Daily Protease Inhibitor Dosing Option for Use With Ritonavir In Appropriate Patients --
(PRINCETON, N.J. - October 20, 2006) - Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of a new 300 mg single capsule formulation of REYATAZ (atazanavir sulfate) for the treatment of HIV-1 infection in adults as part of combination therapy. Taken once daily along with ritonavir and food as part of a anti-HIV drug regimen, the REYATAZ 300 mg single capsule formulation can replace two REYATAZ 150 mg capsules for: patients who have previously received anti-HIV medicines, patients who will be receiving tenofovir disoproxil fumarate, and patients who have never taken anti-HIV medicines that require SUSTIVA (efavirenz) as part of their anti-HIV drug regimen. The REYATAZ single capsule formulation will be available in the United States within seven business days.
"Bristol-Myers Squibb is committed to helping lead the development and production of innovative once-daily HIV medicines," said Anthony Hooper, president, U.S. Pharmaceuticals, Bristol-Myers Squibb Company. "With the REYATAZ 300 mg single capsule formulation approval, Bristol-Myers Squibb now has one pill, once-daily HIV medicine options available in three drug classes, as part of combination therapy."
REYATAZ is an anti-HIV drug that blocks the action of the HIV protease enzyme, which is needed for the virus to multiply. REYATAZ is a prescription medicine used in combination with other medicines to treat people who are infected with HIV. REYATAZ has been studied in 48-week trials in both patients who have taken or have never taken anti-HIV medicines. REYATAZ does not cure HIV, a serious disease, or help prevent passing of HIV to others. Since REYATAZ (atazanavir sulfate) was initially approved by the FDA in 2003, approximately 129,000 patients in the United States have been treated with the drug. Bristol-Myers Squibb will continue to produce the currently available REYATAZ 200 mg, 150 mg, and 100 mg once-daily capsules.
Important Safety Information About REYATAZ (atazanavir sulfate) 300 mg Capsules:
REYATAZ does not cure HIV or help prevent passing HIV to others.
REYATAZ should not be taken with the following medicines:
ergot medicines, Versed, Halcion, Orap, Propulsid , Camptosar , Crixivan , Mevacor , Zocor , rifampin, St. Johnfs wort, AcipHex , Nexium , Prevacid, Prilosec or Protonix . Viagra , Levitra , Cialis , Vfend , Advair , Flonase , or Flovent should not be used while taking REYATAZ without first speaking with a healthcare provider. This list of medicines is not complete. The use of all prescriptions and nonprescription medicines, vitamins, herbal supplements, or other health preparations should be discussed with a healthcare provider.
The following side effects or conditions should be reported to a healthcare provider right away:
- A change in the way the heart beats may occur and could be a symptom of a heart problem.
- Diabetes and high blood sugar may occur in patients taking protease inhibitor medicines like REYATAZ.
- Yellowing of the skin and/or eyes may occur due to increases in bilirubin levels in the blood (bilirubin is made by the liver).
- Rash (redness and itching) sometimes occurs in patients taking REYATAZ, most often in the first few weeks after the medicine is started, and usually goes away within two weeks with no change in treatment.
- In patients with liver disease, including hepatitis B or C, the liver disease may get worse when taking anti-HIV medicines like REYATAZ.
- Some patients with hemophilia have increased bleeding problems with protease inhibitor medicines like REYATAZ (atazanavir sulfate).
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