New Delhi: Drug firm Strides Arcolab on Friday said its subsidiary Onco Therapies has received approval from the US health regulator USFDA to market generic Paclitaxel injection, used for treating cancers, in the American market.
“Onco Therapies Ltd... has received USFDA approval for Paclitaxel Injection USP, 6 mg/ml packaged in 30 mg/ml, 100 mg/16.7 ml and 300 mg/50 ml multiple dose vials,” Strides Arcolab said in a statement.
The product will be launched immediately through Pfizer, with which it has a tie-up, it added.
“Paclitaxel and Oxaliplatin are part of the oncology portfolio licensed to Pfizer in January 2010 for the US market,” Strides said, adding that as per IMS data, the US market for the generic Paclitaxel is around $40 million.
Paclitaxel is among the products in the drug shortage list of the American Society of Health System Pharmacists and USFDA, it said.
The patent for Paclitaxel was held by Bristol-Myers Squibb (BMS). The drug is used for treating ovarian cancer, breast cancer and lung cancer.
“The company has also received tentative approval for Oxaliplatin injection which according to the IMS data has a US market share of nearly $1.4 billion,” Strides added.
“Oxaliplatin is a chemotherapy drug used for treating advanced cancer of the colon and rectum,” the company said.
Shares of Strides Arcolab were on Friday trading at Rs354.30 in the after noon trade on BSE down 0.21% from previous close.