Drug firm Strides Arcolab on Thursday said it 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 said in a statement.
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 added.
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.
“Carboplatin is part of the oncology portfolio licenced to Pfizer in January, 2010, for the US market and is expected to be launched shortly,” the company said.
The company had 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, it said.
Carboplatin injection are indicated for the initial treatment of advanced ovarian cancer, while Oxaliplatin is used to treat advanced cancer of the colon and rectum.
Shares of Strides Arcolab closed at Rs 398.80 on the BSE today, down 2.29 per cent from their previous close.