Strides Arcolab gets USFDA nod for cancer drug

Drug firm Strides Arcolab today said it has received approval from the US health regulator to market cytarabine injections, used in the treatment of cancer, in the American market.

Onco Therapies Ltd, a wholly owned subsidiary of Strides Arcolab, has received approval for three abbreviated new drug applications of cytarabine injections from the US Food and Drug Administration (USFDA), Strides Arcolab said in a statement.

The company has received approval for "cytarabine injection 20 mg/mL, packaged in 500 mg/25 mL multiple-dose vials, 20 mg/mL, packaged in 100 mg/ 5 mL single-dose vials and 20 mg/mL, packaged in 1,000 mg/50 mL pharmacy bulk packages," it added.

According to IMS data, the US market for cytarabine is worth nearly USD 12.3 million, it added.

Cytarabine is part of Strides' oncology portfolio licenced to Pfizer in January, 2010, for the US market and is expected to be launched shortly, the company said.

Cytarabine is used to treat different forms of leukaemia, including acute and chronic myelogenous and acute lymphocytic leukaemia.

It is also used to treat cancer found in the lining of the brain and spinal cord.

Shares of Strides Arcolab were trading at Rs 399 on the the BSE in the late afternoon today, down 3.68% from their previous close.