Natco Pharma Limited is pleased to announce that its marketing partner, Breckenridge Pharmaceutical Inc., has received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets (generic for ZORTRESS ®),from the U.S. Food and Drug Administration (USFDA). NATCO’s partner BPI plans to launch 0.25 mg, 0.5 mg and 0.75 mg strengths of the product shortly.
The above strengths of Everolimus are indicated in the Prophylaxis of Organ Rejection in Kidney Transplantation and Liver Transplantation. As per industry sales data, ZORTRESS® and its therapeutic equivalents had generated annual sales of $162million during the twelve months ending March 2021 in the US.
