Mylan N.V.
Apr 20, 2017

Mylan Launches Generic Trilafon Tablets

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

(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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