HERTFORDSHIRE, England and
PITTSBURGH, Nov. 24, 2015 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Clozapine
Orally Disintegrating Tablets, 25 mg and 100 mg, the generic
version of Jazz Pharmaceutical's FazaClo®. Mylan
received final approval from the U.S. Food and Drug Administration
(FDA) for its Abbreviated New Drug Application (ANDA) for this
product, which is used for the treatment of severely ill patients
with schizophrenia who fail to respond adequately to standard
antipsychotic treatment.(1)
Clozapine Orally Disintegrating Tablets, 25 mg and 100 mg, had
U.S. sales of approximately $51.1
million for the 12 months ending Sept. 30, 2015, according to IMS Health.
Currently, Mylan has 272 ANDAs pending FDA approval representing
$101.8 billion in annual brand sales,
according to IMS Health. Fifty of these pending ANDAs are potential
first-to-file opportunities, representing $36.1 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) Clozapine Orally Disintegrating Tablets can cause
severe neutropenia, orthostatic hypotension, bradycardia, and
syncope, seizures, myocarditis and cardiomyopathy and has been
shown to increase mortality in elderly patients with
dementia-related psychosis. Any questions should be directed
to the treating physician.
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SOURCE Mylan N.V.