New Delhi: Medicinal Companies Zydus Cadila on Thursday said it had received the final approval of the US health regulator to market Nelaabine injection, used to treat several types of cancer, in the American market with 180-day marketing exclusivity.
The company has received approval from US Food and Medication Administration (USFda) for Nelabine injection 250 mg / 50ml, a generic version of Arranon injection.
Zydus Pharmaceuticals USA Inc., a company unit, has been given the designation of competitive generic therapy (CGT) for the product and therefore qualified for 180 days of exclusivity, said Zydus Cadila in a statement.
According to Iqvia, Nelabine injection has an annual sales of around USD 34.5 million in the US.
This drug is produced at the Jydus group injection manufacturing facility in Ahmedabad and will soon be launched commercially on the US market.
The medicine is chemotherapy medicine and is used to treat certain types of leukemia and lymphoma by slowing or stopping cancer cell growth.
“The FDA approval of Nelaabine injection underlines our long-term commitment to patients by giving them access to generic affordable.” This agreement builds our track record that is proven to be successful in commercializing and getting a significant market share in a complex generic product, “said Sharvil Patel’s Cadila Health Implementing Director.
The company has created a diverse portfolio of more than 50 new drug applications abbreviated (Andas) And will continue to focus on complex generic products because it continues to explore the opportunity to grow US business, he added.
The Zydus Group now has 325 approval and has so far submitted more than 400 and since the starting process of archiving in 2003-04.