PARAMUS, N.J., Feb. 22 /PRNewswire/ -- Mayne Pharma (USA) Inc. today announced the availability of the first generic version of the Carboplatin 600mg/60ml presentation. The US Food and Drug Administration (FDA) granted approval for the company's Abbreviated New Drug Application for Carboplatin 600mg/60ml solution on November 23rd, 2004.
Stuart Hinchen, Mayne Pharma's President of the Americas said that, "Mayne is excited to be able to offer the first generic alternative of the 600mg solution presentation to our customers. This is an important addition for our customers and enables us to offer the full range of Carboplatin presentations."
Additionally, Mr. Hinchen noted that "Like many of our cytotoxic products the 600mg presentation incorporates Onco-Tain(TM) technology."
The Onco-Tain(TM) sheath around both solution and lyophilized cytotoxics gives extra strength to the vial, 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.
Carboplatin is used for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents, and the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy. A warning relating to all Carboplatin products exists regarding potential dose related bone marrow suppression, vomiting, and anaphylactic-like reactions. Mayne Pharma now has Carboplatin Injection available in 50mg/5mL, 150mg/15mL, 450mg/45mL and 600mg/60mL presentations.
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, Mayne Pharma (USA) Inc.,+1-201-225-5572