HERTFORDSHIRE, England and
PITTSBURGH, May 23, 2016 /PRNewswire/ -- Mylan N.V.
(Nasdaq: MYL, TASE: MYL) today announced the U.S. launch of
Doxycycline Hyclate Delayed-Release (DR) Tablets USP, 200 mg, a
generic version of Mayne's Doryx®. Mylan received final approval
from the U.S. Food and Drug Administration (FDA) for its
supplemental Abbreviated New Drug Application (sANDA) and was
awarded 180 days of marketing exclusivity for this product.
Doxycycline Hyclate DR Tablets are a tetracycline-class
antimicrobial indicated as adjunctive therapy for severe acne.
Doxycycline Hyclate DR Tablets USP, 200 mg, had U.S. sales of
approximately $181.8 million for the
12 months ending March 31, 2016,
according to IMS Health.
Currently, Mylan has 258 ANDAs pending FDA approval representing
$109 billion in annual brand sales,
according to IMS Health. Forty-five of these pending ANDAs are
potential first-to-file opportunities, representing $37.4 billion in annual brand sales, for the 12
months ending December 31, 2015,
according to IMS Health.
Mylan is a global pharmaceutical company committed to setting
new standards in healthcare. Working together around the world to
provide 7 billion people access to high quality medicine, we
innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We offer a growing
portfolio of more than 1,400 generic and branded pharmaceuticals,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS in the developing world depend.
We market our products in approximately 165 countries and
territories. Our global R&D and manufacturing platform includes
more than 50 facilities, and we are one of the world's largest
producers of active pharmaceutical ingredients. Every member of our
nearly 35,000-strong workforce is dedicated to creating better
health for a better world, one person at a time. Learn more at
mylan.com.
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SOURCE Mylan N.V.