Advertisement
04/13/2021

FDA gives tentative nod for Natco’s Imbruvica generic

The tentative approval applies to the chronic lymphocytic leukemia/small lymphocytic lymphoma treatment in strengths of 560 mg, 420 mg, 280 mg, and 140 mg.
David Salazar
Managing Editor
David Salazar profile picture

Natco Pharma has received tentative approval from the Food and Drug Administration for its generic of Imbruvica (imatinib tablets). The tentative nod applies to the chronic lymphocytic leukemia/small lymphocytic lymphoma treatment in strengths of 560 mg, 420 mg, 280 mg, and 140 mg.

The company said that it believes it is eligible for 180 days of sole generic marketing exclusivity for the product in these dosage strengths.

Imbruvica had annual sales of $3.7 billion for the year ended December 2020, according to industry sales data.

Advertisement
Advertisement