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news.US-based pharmaceutical firm Mylan has launched Naloxone Hydrochloride Injection USP, 0.4mg/mL packaged in 1mL single-dose vials.
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The product was determined to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Naloxone Hydrochloride Injection 0.4mg/mL, of Hospira.
The 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.
The US Food and Drug Administration (FDA) has also approved the abbreviated new drug application (ANDA) for the product.
The company said that the Naloxone Hydrochloride Injection is preservative free and not made with natural rubber latex.
Mylan offers a growing portfolio of over 1,300 generic pharmaceuticals and several brand medications.
Additionally, the company provides a wide range of antiretroviral therapies, upon which about 40% of HIV/AIDS patients in developing countries depend.