Natco Pharma files new drug applications with USFDA

Natco Pharma has filed new product applications with the US health regulator for generic version of drugs used in the treatment of nervous system disease and cancer.

The company has filed Abbreviated New Drug Applications (ANDAs) for Fingolimod, 0.5 mg capsules and Cabazitaxel, 60mg/ 1.5ml injection, with the US Food and Drug Administration, through its respective marketing partners, Natco Pharma said in a filing to the BSE.

"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," it added.

Novartis sells Fingolimod 0.5mg capsules under the brand name Gilenya in the US market. It is used for the treatment of certain patients with multiple sclerosis.

The market size of Gilenya in the US is around $1.2 billion for twelve months ending September 2014, according to IMS Health sales data.

Sanofi sells Cabazitaxel injection under brand name Jevtana, in the US. The drug is used to treat certain patients with hormone-refractory prostate cancer.

As per IMS Health sales data, the market size of Jevtana in the US was around $116.8 million for the 12 months ended September 2014.

Natco scrip closed at Rs 1,420.50, up 4.49%, on the BSE.