Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited (Strides) today announced that it has received approvals from US FDA for Carboplatin Injection 10 mg/ mL (Aqueous solution), packaged in 1000 mg/ 100 mL and PharmacyBulk Packages. Oxaliplatin for Injection USP (Lyopholized) is  packaged in 50 mg and 100 mg single-use vials has received a Tentative approval. The drugs will that which was spun off as a separate division post the company’s restructuring in 2009.

The Company had earlier received approval for Carboplatin Injection 10 mg/ mL packaged in 50 mg/ 5mL, 150 mg/ 15 mL, 450 mg/ 45 mL and 600 mg/ 60 mL Multi-dose vials.

According to IMS data, the US market for generic Carboplatin is approximately US$ 35 million. Carboplatin is part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly.

According to IMS data, the US market for Oxaliplatin is approximately USD 1.4 Billion. The Company had earlier received tentative approval for Oxaliplatin Injection, 5 mg / mL, packaged in 50 mg / 10mL, 100 mg/ 20 mL, and 200 mg/ 40 mL single dose vials. While other generic Companies approved for this product are expected to launch the product in August 2012, Strides will issue further updates on this product in April 2012.

Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents, and in secondary treatment of advanced ovarian carcinoma which has recurred after prior chemotherapy.

Oxaliplatin is a chemotherapy drug used to treat advanced cancer of the colon and rectum. It is used in combination with other medications to slow or stop cancer cell growth.

Agila Specialties 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. It is amongst the largest lyophilization (freeze drying) capacities in the world. Agila’s marketing network covers 70 countries and it has partnerships with some of the world’s leading pharmaceutical companies for both developed and emerging markets.

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. The company has 14 manufacturing facilities across 6 countries with presence in more than 75 countries in developed and emerging markets. Manufacturing is ably supported by a 350-scientist strong global R&D Centre located in Bangalore.