PARAMUS, N.J., July 30 /PRNewswire/ -- Mayne Pharma (USA) Inc. announces that the US Food and Drug Administration (FDA) has granted approval for the company's Abbreviated New Drug Application for Fluconazole Injection mini bags.
Stuart Hinchen, Mayne Pharma's President of the America's said, "Adding Fluconazole to our growing list of products is a very exciting step for Mayne. It builds on our hospital offering, increases the therapeutic categories in which we offer products from pain management, cancer, hypertension and heart disease to now also include anti-infectives, as well as demonstrating our capacity to now offer products in mini-bags." Additionally, Mr. Hinchen noted that "for increased patient safety all our Fluconazole presentations are unit- of-use bar-coded, a feature that we have on all our products."
Fluconazole is used for the treatment of systemic fungal infections. Mayne Pharma will be making Fluconazole Injection (2mg/mL) in 0.9% Sodium Chloride injection available in 10 packs of 200 mg/100 mL and 400 mg/200 mL mini bags.
Mayne Group Limited, the parent of Mayne Pharma (USA) Inc. has businesses in pharmaceuticals (the manufacture of oral and injectable pharmaceuticals for distribution to more than 50 countries) as well as Australian-based businesses in diagnostic services (pathology, diagnostic imaging and medical centres), pharmacy and health-related consumer products.
Mayne Pharma (USA) Inc.
CONTACT: Joe Marchese, VP Sales and Marketing, +1-201-225-5572, forMayne Pharma (USA) Inc.