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Mayne Pharma USA Inc. Receives FDA Approval For Multi Dose Carboplatin


10/19/2005 5:09:00 PM

PARAMUS, N.J., July 26 /PRNewswire/ -- Mayne Pharma (USA) Inc. today announced that on June 10, they received approval for their labels, cartons and package inserts to reflect multi dose labeling on their Carboplatin 50mg/5mL, 150mg/15mL, 450mg/45mL and 600mg/60mL solution presentations.

Mayne has the first and only generic Carboplatin 600mg/60mL multi dose solution presentation.

All newly manufactured product will be labeled with multi dose labels. In the meantime, any existing vials with the single dose label will be considered as multi dose products by the Centers for Medicaid and Medicare Services (CMS).

Mayne's Carboplatin is also differentiated by the Onco-Tain(TM) sheath, which is applied to all of Mayne's cytotoxic products, giving the vial extra strength, reducing breakage and enhancing pharmacy safety. Unlike opaque plastic vials, the Onco-Tain(TM) vial retains the clarity of glass, ensuring easy inspection of the contents. Moreover, the Onco-Tain(TM) sheath acts as a barrier between the glass surface and human skin.

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 centers), pharmacy and health-related consumer products.

Media and investor enquiries Mayne Group Limited Larry Hamson General Manager Corporate Relations Ph: +61 3 9868 0380 Mb: +61 3 407 335 907

Mayne Pharma (USA) Inc.

CONTACT: Larry Hamson, General Manager Corporate Relations of Mayne GroupLimited, +61-3-9868-0380, or cell, +61-3-407-335-907



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