Breaking News

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.
blog comments powered by Disqus
  • What’s New at La Prairie?

    What’s New at La Prairie?

    Melissa Meisel, Associate Editor||April 25, 2016
    VP of marketing shares the latest buzz with Happi.

  • Mapping Out Multicultural Beauty

    Mapping Out Multicultural Beauty

    April 25, 2016
    Agnieszka Saintemarie of Kline Group about current trends and challenges in multicultural beauty.

  • At a Loss for Curls?

    April 22, 2016
    Amplixin, a Miami-based maker of hair strengthening products, has a solution for hair loss.

  • Who Makes That?

    Who Makes That?

    Tom Branna, Editorial Director||April 1, 2016
    From concept and formulation to testing and filling, today’s contract manufacturers perform a range of services for marketers

  • Multi-Cultural Beauty Update

    Multi-Cultural Beauty Update

    Christine Esposito, Associate Editor||April 1, 2016
    Established brands and start-ups address the needs of multi-cultural beauty consumers.

  • The Scalp Microbiome

    The Scalp Microbiome

    Nava Dayan PhD, Dr. Nava Dayan LLC||April 1, 2016
    A review of recent findings and innovative approaches for treating scalp disorders.