PITTSBURGH, Aug. 6, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Etomidate Injection USP, 2 mg/mL packaged in 40 mg/20 mL single-use vials. This product is the generic version of Hospira's Amidate® Injection, which is indicated by intravenous injection for the induction of general anesthesia. Etomidate Injection USP, 2 mg/mL, in all product presentations has faced recent shortages in the U.S. market.
Etomidate Injection USP, 2 mg/mL, packaged in 20 mL vials, had U.S. sales of approximately $6.58 million for the 12 months ending March 31, 2012, according to IMS Health. Mylan has begun shipping the 20 mL vial presentation of this product in packs of 10.
Currently, Mylan has 169 ANDAs pending FDA approval representing $83 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.1 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.
Mylan Institutional, part of Mylan Inc., is a customer-focused business providing a differentiated basket of pharmaceutical products and services, including a broad range of injectable products and SKU's in unit dose, unit-of-use, and automation-ready package formats, to institutional
customers, which include group purchasing organizations, wholesalers, hospitals, surgical and radiology services, home infusion service providers, long-term care facilities, correctional facilities, specialty pharmacies, veterinary clinics and retail outlets.
Mylan is a global pharmaceutical company committed to setting new standards in health care. 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 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 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 150 countries and territories. Our workforce of more than 18,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com
SOURCE Mylan Inc.