HERTFORDSHIRE, England and PITTSBURGH, April 11, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Metoprolol Tartrate Tablets USP, 37.5 mg and 75 mg, which is the generic version of Novartis' Lopressor® Tablets. These strengths are the first and only available intermediate dosage strengths between the existing Metoprolol Tartrate Tablets USP strengths of 25 mg, 50 mg and 100 mg. Mylan currently is the only manufacturer that offers Metoprolol Tartrate Tablets in five strengths.
Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Supplemental Abbreviated New Drug Application (ANDA) for its Metoprolol Tartrate Tablets, 37.5 mg and 75 mg, which is indicated for the treatment of hypertension.(1)
Metoprolol Tartrate Tablets 25 mg, 50 mg and 100 mg strengths had U.S. sales of approximately $68.9 million across all manufacturers for the 12 months ending Feb. 29, 2016, according to IMS Health.
Currently, Mylan has 265 ANDAs pending FDA approval representing $110.3 billion in annual brand sales, according to IMS Health. Forty-eight of these pending ANDAs are potential first-to-file opportunities, representing $38.3 billion in annual brand sales, for the 12 months ending Dec. 31, 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 nearly 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) Metoprolol is contraindicated in patients with cardiogenic shock, overt cardiac failure and severe peripheral arterial circulatory disorders. It is also contraindicated in patients with certain cardiac conduction problems like bradycardia, second and third degree heart block, and sick-sinus syndrome. Metoprolol should be discontinued through a gradual reduction in dosage, exacerbations of angina and myocardial infarctions have occurred when metoprolol has been discontinued abruptly. Patients should consult their physician if they have any questions before starting or stopping metoprolol.
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SOURCE Mylan N.V.