Breckenridge wins final US FDA approval for Imatinib Mesylate Tablets ANDA
5 March 2019 -

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.