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We will see more of this...but for 'another' reason. How can it not...do
you have any idea how many computers are between the raw materials and
your medicine cabinet. Think about it.

Your concerned cyber sis,
Gail Vass, R.N.

http://www.pslgroup.com/dg/90d4e.htm

Abbott Having Difficulty With Norvir Capsules,
Will Substitute With Liquid

ABBOTT PARK, IL -- July 28, 1998 -- Abbott Laboratories announced that
it is experiencing manufacturing difficulties with the capsule
formulation of its HIV protease inhibitor, Norvir(R) (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 of 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," Higgins said. "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.

Norvir is indicated in adults in combination with other anti-retroviral
agents or, in the United States, as monotherapy for the treatment of HIV
infection. Norvir has also been  cleared by the FDA for use in children
between the ages of two 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.

Related Links: Norvir, Abbott Laboratories