India, Nov. 7 -- Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.
The approved product is therapeutically equivalent to Sprycel Tablets (Bristol-Myers Squibb Company), the reference listed drug (RLD). Dasatinib Tablets are indicated for the treatment of adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML)—in chronic, accelerated, or blast phases—and Ph+ acute lymphoblastic leukemia (ALL) resistant or intolerant to prior therapy, including imatinib. They are also approved for pediatric patients aged on...