Strides Arcolab receives US FDA approval for cladribine injection

Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited (Strides) today announced that it has received US FDA approval for cladribine injection 1 mg/ ML packaged in 10 mg/ 10 mL single dose vials.

According to IMS data, the US market for generic Cladribine is approximately US$ 5.3 million with only one major player.

Cladribine is part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market.

The product is expected to be launched shortly.

With 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.

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 leukaemia.

Agila is the specialties unit of Strides Arcolab is focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from 8 world-class global manufacturing facilities, including one of the largest steriles capacity in India and amongst the largest lyophilization (freeze drying) capacities in the world.

Strides Arcolab is a global pharmaceutical company that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.