Abbott Laboratories Submits New Drug Application
to U.S. FDA for Reformulated Norvir
ABBOTT PARK, Ill., March 31 -- Abbott Laboratories today announced it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for Norvir (ritonavir) soft-gel capsules. Norvir is an HIV protease inhibitor for the
treatment of patients with HIV infection and AIDS. A regulatory filing is
currently under review by the European Agency for the Evaluation of Medicinal
Products (EMEA) following a submission to the agency in January 1999.
Regulatory filings in other countries where Norvir is sold will occur
throughout 1999.
The filing follows intense reformulation work at Abbott
after an announcement in July 1998 that a new crystalline
structure of ritonavir, which affected how the capsule dissolved, would interrupt
the production of Norvir capsules.
In the interim, Abbott increased production of the liquid
form of ritonavir to allow patients to continue therapy without
interruption.
The application provided to regulatory authorities was
based in part on a soft-gel capsule formulation of Norvir in development
prior to the capsule supply shortage encountered last year. The product was
reformulated to accommodate a new and stable crystalline structure of
ritonavir.
Abbott cannot predict the timing for product approvals
worldwide. In the interim, Norvir oral solution (liquid) will continue to
be available to all Norvir consumers.
In the United States, Norvir is indicated in adults in
combination with other antiretroviral agents or as monotherapy for the
treatment of HIV infection for patients with advanced disease. This
indication is based on the results from a study that showed a reduction in both
mortality and AIDS defining events for patients who received Norvir.
Median duration of follow-up in this study was six months. The clinical
benefit of Norvir for longer periods of treatment is unknown for patients with
less advanced disease.
This indication is based on changes in surrogate markers
in studies evaluating patients who received Norvir alone or in
combination with other antiretroviral agents. Norvir has also been approved by
the FDA for use in children between the ages of 2 and 16 based on safety
and pharmacokinetic data. In the European Union, Norvir is
indicated in combination with anti-retroviral nucleoside analogue(s)
for the treatment of HIV-1 infected patients with advanced or progressive immunodeficiency. Norvir has also been cleared by the
EMEA for use in children over 2 years of age.
Norvir is not a cure for HIV infection. People treated
with Norvir may continue to acquire illnesses associated with advanced
HIV infection, including opportunistic infections. Norvir may not be
right for everyone, including people with liver disease, hepatitis or
hemophilia. Redistribution/accumulation of body fat have been
observed in patients receiving protease inhibitors. Elevated blood sugar
levels have been reported in patients taking protease inhibitors. Allergic
reactions ranging from mild to severe have been reported. Common adverse
reactions include fatigue, vomiting, diarrhea, loss of appetite,
abdominal pain, taste disturbance, tingling sensation or numbness in the hands,
feet, or around the lips, headache and dizziness. Norvir should not be
used with certain medications including some non-sedating antihistamines,
sedative hypnotics, antiarrhythmics or ergot alkaloid
preparations. Patients should talk with their physician or pharmacist. For more
information about the currently available Norvir liquid formulation, see the
Norvir full prescribing information.
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