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
  • Senior Skin Care

    Senior Skin Care

    Christine Esposito, Associate Editor||July 19, 2016
    McCord Research and Product Quest Manufacturing roll out new hospital-grade skin care kits for seniors to use at home.

  • Naterra Expands Tree Hut Range

    Naterra Expands Tree Hut Range

    Melissa Meisel, Associate Editor||July 18, 2016
    New ‘Bare’ collection is out now.

  • An Antioxidant Arsenal

    An Antioxidant Arsenal

    July 11, 2016
    BioRewind is Dermarché Labs' new anti-aging regimen that delivers broad-spectrum antioxidant protection against free radicals

  • Sustainability is Omnipresent

    Sustainability is Omnipresent

    Christine Esposito , Associate Editor||July 1, 2016
    Industry stakeholders convene in New York City for Organic Monitor’s annual event

  • Perceived Perfection

    Perceived Perfection

    Christine Esposito, Associate Editor||July 1, 2016
    From primers to pressed powders, facial cosmetics help create the illusion of a flawless complexion.

  • Preserve & Serve

    Preserve & Serve

    Melissa Meisel , Associate Editor||July 1, 2016
    Suppliers with innovative preservatives provide staying power for formulations.