Strides receives USFDA approval for cancer drugs
25 November 2011: Drug firm, 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. It has earlier received approval for Carboplatin injections in strengths of 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.
Source: HinduBusinessLine |