Breckenridge gets FDA nod for generic Gleevec

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Breckenridge gets FDA nod for generic Gleevec

By Sandra Levy - 03/05/2019
Breckenridge Pharmaceutical has received the Food and Drug Administration's clearance for its generic Gleevec (imatinib mesylate tablets).

The generic of Novartis' branded drug is indicated to treat certain types of cancer (such as acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors, and myelodysplastic/myeloproliferative diseases). It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.

Breckenridge's generic Gleevec was developed in collaboration with Stason Pharmaceuticals and will be commercially manufactured by Stason in 100-mg and 400-mg dosage strengths.

The product had a market value of approximately $654.8 million for the year ended Dec. 31, 2018, according to industry sales data.

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