HERTFORDSHIRE, England and
PITTSBURGH, Sept. 28, 2015 /PRNewswire/ -- Mylan N.V.
(Nasdaq: MYL) today announced the U.S. launch of Paliperidone
Extended-Release Tablets 1.5 mg, 3 mg, 6 mg and 9 mg, the generic
version of Janssen's Invega®. 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 indicated for
the treatment of schizophrenia in adults and adolescents (12 – 17
years of age) in addition to schizoaffective disorder as
monotherapy and as an adjunct to mood stabilizers and/or
antidepressants in adults. (1)
Paliperidone Extended-Release Tablets 1.5 mg, 3 mg, 6 mg and 9
mg, had U.S. sales of approximately $606.2
million for the 12 months ending June
30, 2015, according to IMS Health.
Currently, Mylan has 260 ANDAs pending FDA approval representing
$98.7 billion in annual brand sales,
according to IMS Health. Fifty of these pending ANDAs are potential
first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12
months ending December 31, 2014,
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 around 1,400 generic pharmaceuticals and several brand
medications. In addition, we offer a wide range of antiretroviral
therapies, upon which nearly 50% of HIV/AIDS patients in developing
countries depend. We also operate one of the largest active
pharmaceutical ingredient manufacturers and currently market
products in about 145 countries and territories. Our workforce of
approximately 30,000 people is dedicated to creating better health
for a better world, one person at a time. Learn more at
mylan.com.
(1) Paliperidone Extended-Release Tablets is an atypical
antipsychotic and is not approved for the treatment of patients
with dementia-related psychosis. Elderly patients with
dementia-related psychosis treated with antipsychotic drugs are at
an increased risk of death.
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SOURCE Mylan N.V.