Strides Arcolab’s arm receives USFDA nod for Topotecan Hydrochloride Injection

29 Aug 2012 Evaluate

Strides Arcolab’s wholly owned subsidiary Onco Therapies has received US Food and Drug Administration (FDA) approval for Abbreviated New Drug Application (ANDA) Topotecan Hydrochloride Injection 4mg (base), packaged in single dose vials. The generic market for generic Topotecan is about $51 million.

Topotecan is a part of the Oncology portfolio licensed to Pfizer for the US market and the product is available for immediate launch.

Strides Arcolab is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures wide range of IP-lead niche pharmaceutical products with an emphasis on sterile injectables.

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