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Sciences Refiles New Drug Application with the FDA for Single-Tablet
Regimen of Truvada and TMC278
City, Calif. -- February 10, 2011 -- Gilead Sciences, Inc.
(Nasdaq:GILD) announced today that it has refiled a New Drug
Application (NDA) with the U.S. Food and Drug Administration
(FDA) for the single-tablet regimen of Truvada (emtricitabine
and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals'
investigational non-nucleoside reverse transcriptase inhibitor
TMC278 (rilpivirine hydrochloride) for HIV-1 infection in
Gilead previously submitted an NDA for the single-tablet regimen
of Truvada/TMC278 on November 23, 2010. The company announced
on January 25, 2011 that it had received a "refuse to
file" notification from the FDA regarding that submission.
Specifically, the FDA requested additional information on
the analytical methodology and qualification data used to
establish acceptable levels of recently identified degradants
related to emtricitabine; this information has been included
in the refiling.
The FDA has up to 60 days to conduct a preliminary review
to assess whether the NDA is sufficiently complete to permit
a substantive review. The FDA will establish a target action
date for the NDA, under the Prescription Drug User Fee Act
(PDUFA), if the application is formally filed.
Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet
medical need. The company's mission is to advance the care
of patients suffering from life-threatening diseases worldwide.
Headquartered in Foster City, California, Gilead has operations
in North America, Europe and Australia.
Sciences. Gilead Sciences Refiles New Drug Application with
the FDA for Single-Tablet Regimen of Truvada and TMC278. Press
release. February 10, 2011.