US-based Breckenridge Pharmaceutical Inc, a subsidiary of Towa Pharmaceutical, announced on Tuesday that it has been granted final approval from the United States Food and Drug Administration (FDA) for its Everolimus Tablets (generic for Zortress).
The product was produced in partnership with Natco Pharma Limited. The company is planning to launch Everolimus Tablets in 0.25mg, 0.5mg and 0.75mg strengths during the third quarter of 2021 in a blister card packaging configuration.
According to industry sales data, Zortress and its therapeutic equivalents generated USD162 million in annual sales for the twelve months ending March 2021.
ScinoPharm Taiwan secures first US FDA approval for complex multiple sclerosis generic
ScinoPharm Taiwan's Glatiramer Acetate Injection approved by US FDA
International Isotopes Inc to change name to Radnostix Inc
Galmed Pharmaceuticals reports topline results for combination of Aramchol, Stivarga and metformin
Ingenus Pharmaceuticals' generic equivalent to Premarin receives US FDA approval
EirGenix signs second global exclusive licensing deal with Sandoz
Padagis invests USD36m to expand manufacturing in Minneapolis
Newbury Pharmaceuticals gains Danish approval for generic ivermectin cream