Abbott Receives U.S. FDA Approval for Heat-Stable Norvir® (ritonavir) Tablets

AbbottAbbott announced that the U.S. Food and Drug Administration (FDA) has granted approval of a new tablet formulation of the company's antiretroviral medication Norvir® (ritonavir). The new Norvir tablets can be stored at room temperature and do not require refrigeration, making it more convenient for patients. The Norvir tablets and the Norvir soft-gelatin capsules both contain 100 mg of ritonavir. While the rate of drug absorbed is different, there is no requirement for dosage change. Norvir is used in combination with other antiretroviral medications to treat HIV. All forms of Norvir, including the soft-gel capsule and liquid form, remain available in the United States.

"Norvir has been a critical component of HIV treatment for many patients. The innovation behind the development of the Norvir tablet is the direct result of years of effort by Abbott scientists to address the needs of people living with HIV," said Scott Brun, M.D., divisional vice president, infectious disease development, Global Pharmaceutical Research and Development, Abbott. "Abbott has been dedicated to finding new and more convenient ways for patients to manage their HIV through the development of novel diagnostics testing methods and medications for more than 20 years."

Abbott scientists evaluated several candidate formulations before developing the final Norvir tablet formulation. The Norvir tablet was developed using Abbott's Meltrex® technology, a proprietary melt-extrusion process, making it more heat-stable. This is the same technology used to develop Abbott's Kaletra® (lopinavir/ritonavir) tablet, which combines lopinavir and ritonavir.

"Approximately one-third of all HIV-positive patients in treatment use Norvir in combination with other antiretroviral medicines. The heat-stable tablet formulation may allow these patients greater flexibility to store and carry their medication with them," said Renslow Sherer, M.D., professor of medicine, section of infectious diseases and global health and director, International HIV Training Center, University of Chicago Hospitals. "For patients who may not have access to refrigeration, this new formulation is also important."

For more than 20 years, Abbott has made a significant contribution to the fight against HIV/AIDS through the development of innovative tests and medicines.

  • In 1985, Abbott developed the first licensed test to detect HIV antibodies in the blood. The company remains a leader in HIV diagnostics today
  • In 1992, Abbott was the first company to receive FDA approval for an HIV diagnostic assay. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply
  • In 1996, Norvir was approved for the treatment of HIV in the United States. Norvir was one of the first protease inhibitors on the market and remains one of the most commonly prescribed medicines as part of combination therapy
  • In 1997, Norvir became one of the first protease inhibitors to receive FDA clearance for use in children
  • In 2000, Abbott received FDA accelerated approval for Kaletra
  • In 2005, the tablet form of Kaletra received FDA approval
  • In 2006, Kaletra tablets received EMEA approval
  • In 2007, Abbott received FDA approval for a new lower-strength Kaletra tablet suitable for pediatric use
  • In 2007, Abbott's RealTime HIV-1 Viral Load test was approved by the FDA for use on the m2000™ molecular diagnostics instruments
  • In 2009, Abbott received approval from the FDA for its ABBOTT PRISM HIV O Plus test, the first fully-automated blood screening test for HIV-1/HIV-2
  • In 2010, the FDA approved the new Norvir tablet

More information may also be found on Abbott.com/HIV.

About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.

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