PARAMUS, N.J., Oct. 14 /PRNewswire/ -- Mayne Pharma (USA) Inc. today announced that the US Food and Drug Administration (FDA) had granted approval for the company's Abbreviated New Drug Application for Carboplatin Injection.
Stuart Hinchen, Mayne Pharma's President of the Americas said that adding Carboplatin further extends Mayne's specialty focus in the oncology field, building on last year's launch of Paclitaxel.
"We have a broad range of cancer drugs for the US market and Carboplatin injection is another important addition for our customers," Mr Hinchen said. Additionally, Mr. Hinchen noted that, "many of our cytotoxic products incorporate Onco-Tain(TM) technology, which helps minimize accidents in the pharmacy".
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.
Mayne Pharma's injectable cytotoxic product range also feature a red cytotoxic warning band prominently displayed on the boxes for easy identification of these drugs. This feature is distinctive to Mayne Pharma cytotoxic packs and helps ensure that all hospital staff who handle the products recognize that the contents require additional caution-and treat them accordingly. In addition, all Mayne Pharma Carboplatin presentations are unit-of-use bar-coded, a feature that exists for all Mayne Pharma products.
"We are a company focused on servicing our hospital customers with increasing numbers of innovative products and presentations, and offering safety features that meet the user's needs, especially in a high risk area such as cytotoxics" concluded Mr. Hinchen.
Carboplatin is used for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. A warning relating to all Carboplatin products exists regarding potential dose related bone marrow suppression, vomiting, and anaphylactic-like reactions. Mayne Pharma will be making Carboplatin Injection available in 50mg/5mL, 150mg/15mL and 450mg/45mL 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.