Mylan Inc, a global pharmaceutical company committed to setting new standards in health care, 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 US 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 US sales of approximately $12.3 million for the 12 months ending December 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.