Strides Arcolab has received approval from the US health regulator to market two generic cancer drugs in the American market. Onco Therapies Ltd, a unit of Strides Arcolab, has received approval from the US Food and Drug Administration (USFDA) for marketing injectable Carboplatin and tentative approval for marketing Oxaliplatin USP for injections.
The company has received a nod for marketing Carboplatin injections in strengths of 10 mg/mL (aqueous solution), packaged in 1,000 mg/100 mL pharmacy bulk packages. In addition, it has tentative approval for marketing Oxaliplatin in 50-mg and 100-mg single-use vials. According to IMS data, the US market for generic Carboplatin is worth nearly $ 35 million, while it stands at about $ 1.4 billion for Oxaliplatin.
