Strides Arcolab gets ANDA approval for two new drugs
Bangalore-based pharma company, Strides Arcolab Limited today announced that it has received approval for two Abbreviated New Drug Applications (ANDAs) filed with Para IV certification to market Granisetron chemotherapy. Granisetron hydrochloride injection will be made available in 0.1 mg per ml and 1.0 mg per ml single-dose vials and 4 mg per 4 ml multi-dose vials. According to 2009 IMS data, the US market for Granisetron hydrochloride injection approximated $26 million.
This is likely to be launhced shortly, the company said in a filing to Bombay Stock Exchange.
Granisetron is the fourth product being launched under the partnership between Strides and Sagent Pharmaceuticals whereing Strides is developing and supplying more than 25 injectible products for the US market which will be marketed by Sagent.
Granisetron hydrochloride injection is the generic equivalent of Kytril from F Hoffmann-La Roche AG. It is indicated for the prevention of nausea and or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose displatin.
Commenting on the development, Ravi Seth, chief executive officer, international operations of Strides said: "With 20 ANDA approvals in the sterile injectables space, Strides is set to grow its presence in the US market. Each approval constitutes an important milestone for the Strides Sagent partnership which continues to acquire scale."