Natco files new drug applications with USFDA
The applications have been filed for Fingolimod and Cabazitaxel, used to fight nervous system diseases and cancer.
New Delhi, February 11, 2015: Natco Pharma has filed for new product applications with the US Food and Drug Administration (USFDA) for generic version of drugs used in the treatment of nervous system disease and cancer. According to a filing to the BSE, Natco Pharma said that the company has filed Abbreviated New Drug Applications (ANDAs) for Fingolimod, 0.5 mg capsules and Cabazitaxel, 60mg/1.5ml injection, with the USFDA, through its respective marketing partners.
Natco and its associated marketing partners for the above products in the US, believe that they are the first company to have filed a substantially complete ANDA which includes a paragraph IV certification for Fingolimod capusles and Cabazitaxel injection, providing 180 days of marketing exclusivity upon its final USFDA approval, the company added.
It may be noted here that Novartis sells the Fingolimod 0.5mg capsules under the brand name Gilenya in the US market. The market size of Gilenya in the US is close to US$ 1.2 billion for the 12 month period ending September 2014, according to the IMS Health data.