Mylan Launches Generic Unasyn® for Injection

Sep 14, 2015, 07:30 ET from Mylan N.V.

HERTFORDSHIRE, England and PITTSBURGH, Sept. 14, 2015 /PRNewswire/ -- Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Ampicillin and Sulbactam for Injection USP, 1.5 g/vial (1 g Ampicillin as the Sodium Salt and 0.5 g Sulbactam as the Sodium Salt), and 3 g/vial (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt), and 15 g, Pharmacy Bulk Package, (10 g Ampicillin as the Sodium Salt and 5 g Sulbactam as the Sodium Salt), the generic version of Pfizer's Unasyn®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for these products, which are indicated for the treatment of infections due to susceptible strains of designated microorganisms in skin and skin structure infections, intra-abdominal infections and gynecological infections.

Ampicillin and Sulbactam for Injection USP, 1.5 g/vial and 3 g/vial and 15 g, Pharmacy Bulk Package, had U.S. sales of approximately $29 million for the 12 months ending June 30, 2015, according to IMS Health. Mylan's launch of this product adds to the company's growing portfolio of more than 145 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 262 ANDAs pending FDA approval representing $99.3 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.

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SOURCE Mylan N.V.



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