HERTFORDSHIRE, England and
PITTSBURGH, April 20, 2017 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL), today announced the U.S. launch of
Perphenazine Tablets USP, 2 mg, 4 mg, 8 mg and 16 mg, a generic
version of the reference listed drug, Trilafon Tablets 2 mg, 4 mg,
8 mg and 16 mg, originally marketed by Schering. 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 in the treatment of schizophrenia and for the control of
severe nausea and vomiting in adults. (1)
Perphenazine Tablets USP, 2 mg, 4 mg, 8 mg, and 16 mg, had U.S.
sales of approximately $41 million
for the 12 months ending Feb. 28,
2017, according to IMS Health.
Currently, Mylan has 236 ANDAs pending FDA approval representing
approximately $104.3 billion in
annual brand sales, according to IMS Health. Forty-six of these
pending ANDAs are potential first-to-file opportunities,
representing $42.7 billion in annual
brand sales, for the 12 months ending Dec.
31, 2016, 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 approximately 7,500 marketed products around the
world, including antiretroviral therapies on which approximately
50% of people being treated for HIV/AIDS in the developing world
depend. We market our products in more than 165 countries and
territories. We are one of the world's largest producers of active
pharmaceutical ingredients. Every member of our more than
35,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com.
(1) Patients with dementia-related psychosis who are treated
with antipsychotic drugs are at an increased risk of death as shown
in short-term controlled trials. The deaths appeared to be either
cardiovascular (e.g., heart failure, sudden death) or infectious
(e.g. pneumonia) in nature. This drug is not approved for the
treatment of patients with dementia-related psychosis.
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SOURCE Mylan N.V.