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3TC Once Daily Approved
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FDA approved on, June 26, 2002, a supplemental new drug application from
GlaxoSmithKline expanding the labeled indication to provide for the use of
Epivir (lamivudine) once daily for the treatment of HIV infection in
combination with other antiretroviral agents, and a new 300 mg tablet. The
product label has been modified to reflect these changes. The "Dosage and
Administration" section of the label reads:
DOSAGE AND ADMINISTRATION:
Adults: The recommended oral dose of EPIVIR for adults is 300 mg daily,
administered as either
150 mg twice daily or 300 mg once daily, in combination with other
antiretroviral agents (see
DESCRIPTION OF CLINICAL STUDIES, PRECAUTIONS, MICROBIOLOGY, and CLINICAL
PHARMACOLOGY). If lamivudine is administered to a patient dually infected
with HIV and HBV, the dosage indicated for HIV therapy should be used as
part of an appropriate combination regimen (see WARNINGS).
A copy of the complete product label can be found at:
www.fda.gov/cder/approval/index.htm
by clicking "E" in the index and scrolling down to Epivir.
Label is dated 6/25/02
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