Onco Therapies, a division of Agila, which is a wholly owned subsidiary of Strides Arcolab, has received US Food and Drug Administration (FDA) approval for Paclitaxle injection USP, 6mg/ml packaged in 30mg/ml, 100mg/ml and 300mg/ml multiple dose vials.
Paclitaxle injection is among the products in the drug shortage list of the America Society of Health-System Pharmacists and the USFDA. The US market of Paclitaxle is about $46 million. The company will launch the product immediately.
The company has also got tentative approval for Oxaliplatin injection which has a US market of about $1.4 billion.
Recently, Onco Therapies received European Union (EU) approval for Oxaliplantin Injection 5mg/ml (10ml, 20ml and 40ml). This is the second European approval out of the 22 filings made by OTL in the year 2010 for products which have a combined market value of over $5 billion.
Strides Arcolab is global pharmaceuticals company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceuticals products with emphasis on sterlite injectables.
