PITTSBURGH, March 11, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Naloxone Hydrochloride Injection USP, 0.4 mg/mL packaged in 1 mL single-dose vials. Mylan’s product was determined to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Naloxone Hydrochloride Injection 0.4 mg/mL, of Hospira Inc. Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Mylan’s Naloxone Hydrochloride Injection is preservative free and not made with natural rubber latex.
Naloxone Hydrochloride Injection USP, 0.4 mg/mL, had U.S. sales of approximately $12.3 million for the 12 months ending Dec. 31, 2013, according to IMS Health.
Currently, Mylan has 187 ANDAs pending FDA approval representing $94.7 billion in annual sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $24.5 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan’s recent acquisition of Agila, the company now has a total of 311 ANDAs pending FDA approval.
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 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 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% 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 140 countries and territories. Our workforce of more than 20,000 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.
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