Onco Therapies, a wholly owned subsidiary of Indian generics drugmakers Strides Arcolab (BO: 532531), has received approvals from the US Food and Drug Administration for copy versions of two cancer drugs: Carboplatin Injection 10 mg/mL (aqueous solution), packaged in 1,000 mg/100mL, pharmacy bulk packages; and Oxaliplatin for injection USP (lyopholized) packaged in 50mg and 100mg single-use vials (tentative approval).
The company had earlier received FDA approval for Carboplatin Injection 10mg/mL packaged in 50mg/5mL, 150mg/15mL, 450mg/45mL and 600mg/ 60mL multi-dose vials.
According to IMS data, the US market for generic carboplatin is about $35 million and for oxaliplatin is around $1.4 billion. While other generic companies approved for this product are expected to launch their versions in August 2012, Strides says that it will issue further updates on this in April 2012.
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