Strides Arcolab’s arm receives USFDA nod for two Oncology products

19 Oct 2012 Evaluate

Strides Arcolab’s - wholly owned subsidiary - Onco Therapies has received two more ANDA approvals from USFDA for Fludarabine Phosphate for Injection, USP packaged in 50 mg/ 2 mL, Single use vials (25 mg/mg/ mL upon reconstitution) -  Lyophilized format and Idarubicin Hydrochloride Injection, 1 mg/ mL -5 mL, 10 mL and 20 mL Single-dose vials. The combined market for the two drugs is approximately $20 million.

Fludarabine is a chemotherapy drug used to treat chronic lymphocytic leukemia (a type of cancer of the white blood cells) in adults.

Idarubicin belongs to the group of cancer-fighting medications known as antineoplastics. Idarubicin is used alone or in combination with other antineoplastic medications to treat leukemia.

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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