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Norvir Advisory

Abbott Announces Difficulty Manufacturing
Norvir (Ritonavir) Capsules

Company Plans to Substitute With Liquid Formulation

Abbott Park, Illinois, July 27, 1998 Abbott Laboratories announced that it is experiencing manufacturing difficulties with the capsule formulation of its HIV protease inhibitor, Norvir (ritonavir).

"We have encountered an undesired formation of a Norvir crystalline structure that affects how the capsule form of Norvir dissolves," said Arthur Higgins, senior vice president, pharmaceutical operations, Abbott Laboratories. "Although maximum efforts are underway, to date we do not have a solution to the capsule problem."

The manufacturing difficulties with Norvir capsules will result in shortages and interruption in supply capsules. Abbott is planning to supply Norvir oral solution (liquid formulation) to provide continued Norvir therapy for patients.

Norvir capsules currently in distribution are not affected by this issue. When used in accordance with the prescribing information, product on the market is safe and effective.

"We deeply regret this inconvenience," said Higgins. "Abbott is committed to doing everything it can to enable patients to continue Norvir therapy without interruption, and to resuming timely delivery of Norvir capsules."

The active ingredients in Norvir liquid and Norvir capsules are identical, as is their activity against HIV.

Pharmacists and physicians are being informed of dosing instructions to address the capsule-to-liquid conversion.

Abbott has contacted and is working with the U.S. Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other international regulatory agencies to address the problem. Abbott will be communicating with health care providers, consumers and the AIDS community through letters.

In addition, the company has set up a toll-free number for inquiries and has placed information on its website. For health care provider and patient questions regarding Norvir liquid in the United States, call 1-800-637-2400 or visit www.norvir.com.

Norvir is indicated in adults in combination with other anti-retroviral agents for the treatment of HIV infection. Norvir has also been cleared by the FDA for use in children between the ages of 2 and 16 based on safety and pharmacokinetic data.

Norvir may not be right for everyone, including people with liver disease, hepatitis, or hemophilia. 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. Frequently observed adverse events may diminish as therapy is continued. Norvir should not be used with certain medications including some non-sedating antihistamines, sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations.

Posted 8/28/98

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