New Version of Agouron's HIV Protease Inhibitor
To Be in Pharmacies Immediately
LA JOLLA, Calif., March 6 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.
today announced that the Food and Drug Administration (FDA) has approved a
film-coated version of VIRACEPT(R) (nelfinavir mesylate) Tablets. This new
formulation is part of Agouron's continuous efforts to meet the needs of
patients with HIV infection who are being treated with VIRACEPT as part of
their combination antiretroviral regimens.
The film-coated version of VIRACEPT is intended to preserve tablet
integrity, and thereby may diminish the possibility of tablets dissolving
prematurely and tablet breakage. The dosage strength will remain the same.
"We are pleased that the FDA has approved the film-coated version of
VIRACEPT," said Kent Snyder, President, Global Commercial Operations. "For
the long-term management of HIV, it is essential that treatment be made as
simple and easy as possible for patients, to support adherence over time.
Along with the recently approved twice-daily (BID) dosing schedule for
VIRACEPT, this new formulation will further enhance the utility of the most
extensively prescribed HIV protease inhibitor in the United States."
VIRACEPT in combination with other antiretroviral agents is indicated for
the treatment of HIV infection when antiretroviral therapy is warranted. This
indication is based on analyses of surrogate marker changes in patients who
received VIRACEPT in combination with nucleoside analogs or alone for up to
48 weeks. At present, there are no results from controlled trials evaluating
the effect of therapy with VIRACEPT on clinical progression of HIV infection,
such as survival or the incidence of opportunistic infections.
VIRACEPT is generally well-tolerated when taken 1250 mg BID or 750 mg TID.
In study 542, diarrhea of moderate or greater intensity occurred in 14% to
18% of patients receiving VIRACEPT 1250 mg BID or 750 mg TID with stavudine or
lamivudine. New onset or exacerbation of diabetes mellitus and hyperglycemia,
changes in the distribution of body fat, and increased bleeding in patients
with hemophilia types A and B have been reported with protease inhibitors.
For further information about Agouron Pharmaceuticals, Inc., or about
VIRACEPT, please dial toll free 1-888-VIRACEPT (847-2237). To receive full
prescribing information for VIRACEPT via fax, dial 1-888-288-9639.
Agouron Pharmaceuticals, Inc., a wholly owned subsidiary of the
Warner-Lambert Company (NYSE: WLA), is an integrated pharmaceutical company
committed to the discovery, development, manufacturing, and marketing of
innovative therapeutic products engineered to inactivate proteins that play
key roles in cancer, AIDS, and other serious diseases. Agouron employs more
than 1200 people of whom approximately 800 are engaged in research and
development.
VIRACEPT(R) and Agouron(R) are registered trademarks of Agouron
Pharmaceuticals, Inc.
SOURCE Agouron Pharmaceuticals, Inc.
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Related links:
http://www.agouron.com
Company News On-Call:
http://www.prnewswire.com/comp/019650.html or fax,
800-758-5804, ext. 019650
CONTACT:
Joy Schmitt, Director Product Public
Relations of Agouron Pharmaceuticals, Inc., 858-622-3220
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