Onco Therapies Ltd, a wholly-owned subsidiary of Strides Arcolab Ltd, has announced that it has received US FDA approval for Cladribine injection.
Cladribine is part of the oncology (cancer) drug portfolio licensed to Pfizer in January 2010 for the US market. The drug comes in 1 mg/ ml packaged in 10 mg/ 10 ml single dose vials.
Cladribine belongs to the group of cancer-fighting medications known as antineoplastics, and specifically to the group of antineoplastics known as antimetabolites. Cladribine is used to treat a type of blood cancer known as hairy cell leukemia.
The product is expected to be launched shortly. According to IMS data (market intelligence provider), the US market for generic Cladribine is approximately $5.3 million with only one major player.
The company in a release to exchanges said as the approval flow gathering momentum for oncology products, Strides is set to emerge as an important player with complete range of products in this domain.