FDA grants approval for Abbott's antiretroviral medication Norvir

Abbott (NYSE: ABT) announced today 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."




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