Pharmaceutical company Breckenridge Pharmaceutical Inc reported on Monday the receipt of the final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Imatinib Mesylate Tablets in 100mg and 400mg product strengths.
The company added that the ANDA for Imatinib Mesylate Tablets was developed in collaboration with Stason Pharmaceuticals Inc and is the generic version for Gleevec Tablets by Novartis. The Imatinib Mesylate Tablets product will be commercially manufactured by Stason in 100mg and 400mg product strengths.
In conjunction with the US FDA approval, Breckenridge said it plans to launch the product in the near future.
For the year ending 31 December 2018, the Gleevec Tablets generated annual sales of approximately USD654.8m, according to industry sales data.
Alvotech signs biosimilar supply and commercialisation deals with Sandoz
InSysBio agrees new collaborative project with BeOne Medicines
MS Pharma enters strategic partnership with Hetero Group
Apiject to open new generic injectable drug manufacturing facility in Apex, NC
Bionpharma and STEERLife's Etravirine tablets approved by US FDA
ScinoPharm Taiwan secures first US FDA approval for complex multiple sclerosis generic
ScinoPharm Taiwan's Glatiramer Acetate Injection approved by US FDA
Zentiva receives ESG Transparency Award 2025
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