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Mylan Launches Generic Apresoline® Injection

HERTFORDSHIRE, England and PITTSBURGH, May 5, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Hydralazine Hydrochloride Injection USP, 20 mg/mL, which is a generic version of Novartis' Apresoline Injection, 20 mg/mL. 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 severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.

Hydralazine Hydrochloride Injection USP, 20 mg/mL, had U.S. sales of approximately $63.4 million for the 12 months ending March 31, 2016, according to IMS Health. Mylan's launch of this product adds to the company's growing portfolio of more than 150 injectable products available to patients in the U.S. across a broad array of therapeutic categories including oncology, anti-infectives, anesthesia/pain management and cardiovascular.

Currently, Mylan has 263 ANDAs pending FDA approval representing $109.5 billion in annual brand sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $37.5 billion in annual...