Strides Arcolab gains FDA approval for two cancer generics

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Strides Arcolab gains FDA approval for two cancer generics

Genéricos/Novedades | Posted 02/12/2011 0 Post your comment

India-based generics manufacturer Strides Arcolab announced on 24 November 2011 that its wholly-owned subsidiary, Onco Therapies, had gained FDA approval for generic versions of cancer treatments carboplatin and oxaliplatin.

Strides Arcolab received FDA approval for carboplatin injection 10 mg/mL (aqueous solution), packaged in 1,000 mg/100 mL and tentative approval for oxaliplatin injection (lyophilised), packaged in 50 mg and 100 mg single-use vials.

Strides Arcolab had previously received approval for carboplatin injection 10 mg/mL, packaged in 50 mg/5 mL, 150 mg/15 mL, 450 mg/45 mL and 600 mg/60 mL multi-dose vials. The company had also previously received tentative approval for oxaliplatin injection, 5 mg/mL, packaged in 50 mg/10 mL, 100 mg/20 mL and 200 mg/40 mL single dose vials.

Carboplatin is a chemotherapy drug that is usually given to treat ovarian and lung cancer and is a generic version of Bristol-Myers Squibb’s brand-name drug Paraplatin. According to IMS data, the US market for generic carboplatin is approximately US$35 million. Carboplatin is part of the oncology portfolio that Strides Arcolab licensed to Pfizer in January 2010 for the US market and expects the drug to be launched shortly. Generic versions of carboplatin have been available since October 2004.

Oxaliplatin is a chemotherapy drug that is usually given to treat cancer of the large bowel and oesophagus and is a generic version of sanofi-aventis’s brand-name drug Eloxatin. According to IMS data, the US market for oxaliplatin is approximately US$1.4 billion. Other generics companies are expected to launch generic versions of oxaliplatin in August 2012.

Source: Strides Arcolab