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New Delhi, Nov 7 (PTI) Alembic Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic version of Dasatinib tablets used to treat certain types of blood cancer.
The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dasatinib Tablets of strengths 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, Alembic Pharmaceuticals said in a regulatory filing.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS), it added.
Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome p

News 18 India

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