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BASF

November 14, 2005

BASF’s Uvinul Moves Closer
To Becoming FDA-approved
● BASF, Mt. Olive, NJ, is one of the first
companies to receive an approved U.S.
Food and Drug Administration (FDA)
time and extent application (TEA). The
eligible product, Uvinul T 150 UVB
absorber, is one step closer in the
process of being approved for use in
sunscreens in the U.S., BASF executives
said.
TEA, a new FDA regulatory mechanism,
considers data for products
already approved in other countries for
possible authorization as active ingredients
in OTC drugs and related products
in the U.S.
Products that have been marketed
for a minimum of five years in five different
countries, for which appropriate
safety and efficacy data are available,
can be considered for TEA approval,
executives explained. The new procedure
provides an alternative to the
more time-consuming and costly
process of filing a new drug application
(NDA) with FDA.
If approved, Uvinul T 150 will be
added to the OTC monograph, BASF
executives said.
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