04 September 2012 | Regulatory | By BioSpectrum Bureau
Strides subsidiary gets FDA nod for cancer drug
Stride subsidiary’s cancer drug Vinorelbine to be launched through Pfizer following US FDA approval
Singapore: Onco Therapies Limited, a wholly-owned subsidiary of
Strides Arcolab, received final abbreviated new drug application (ANDA) approval for Vinorelbine injection 10 mg/mL packaged in 10 mg/1 mL and 50 mg / 5mL single-dose vials.
Vinorelbine is part of Onco Therapies' oncology portfolio that has been licensed to Pfizer for the US market and the product is available for immediate launch.
Vinorelbine is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cancer cell growth.