PARAMUS, N.J., April 11 /PRNewswire/ -- Mayne Pharma (USA) Inc. announces that the US Food and Drug Administration (FDA) has granted final approval for the company's Abbreviated New Drug Application for Mitoxantrone Injection, USP packaged in 20mg, 25mg and 30mg multiple-dose presentations.
Mitoxantrone is a generic equivalent to Serono's Novantrone(R) which generated annual sales of approximately $75 million in 2005.
Mitoxantrone is expected to be a strong addition to Mayne's existing business in the U.S. and further enhance the range of oncology and hospital-specific specialty products sold in the region.
Mayne Pharma is a global specialty pharmaceutical and health care company. It has offices in 20 countries and distributes in over 30 others, with major operations in the USA, Canada, the UK and Australia. Mayne Pharma's U.S. division specializes in generic injectable pharmaceuticals in a number of defined therapeutic areas, including oncology and anesthesia/pain management, as well as drugs for the treatment of cardiac conditions and to combat hypertension.
Mayne Pharma (USA) Inc.
CONTACT: David Tantillo, +1-201-225-5572, for Mayne Pharma (USA) Inc.