HERTFORDSHIRE, England and
PITTSBURGH, Jan. 19, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ,
TASE: MYL) today announced the U.S. launch of Felbamate Tablets
USP, 400 mg and 600 mg, which is the generic version of
Meda Pharms' Felbatol® Tablets.
Mylan received final approval from the U.S. Food and Drug
Administration (FDA) for its Abbreviated New Drug Application
(ANDA) for this product. Felbamate Tablets are recommended for
monotherapy or adjunctive therapy in the treatment of partial
seizures, with and without generalization, in adults with epilepsy
and as adjunctive therapy in the treatment of partial and
generalized seizures associated with Lennox-Gastaut syndrome in
children.(1)
Felbamate Tablets USP, 400 mg and 600 mg, had U.S. sales of
approximately $53 million for the 12
months ending Nov. 30, 2015,
according to IMS Health.
Currently, Mylan has 269 ANDAs pending FDA approval representing
$101.5 billion in annual brand sales,
according to IMS Health. Fifty of these pending ANDAs are potential
first-to-file opportunities, representing $35.6 billion in annual brand sales, for the 12
months ending June 30, 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 nearly 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 more than
30,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com.
(1) Felbamate should only be used in patients who respond
inadequately to alternative treatments and whose epilepsy is so
severe that the benefits of treatment with Felbamate outweighs the
risk of aplastic anemia and/or liver failure. Felbamate should not
be used in patients with a history of any blood dyscrasias or
hepatic dysfunction. Antiepileptic drugs including Felbamate, have
been observed to increase the risk of suicidal thoughts and
behaviors. Patients should consult their physician with any
questions or concerns before taking Felbamate.
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SOURCE Mylan N.V.