Alembic Pharmaceuticals has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Dasatinib tablets, deemed therapeutically equivalent to Bristol-Myers Squibb’s reference drug, Sprycel. Dasatinib is indicated for adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, as well as chronic, accelerated, or blast phase Ph+ CML and Ph+ acute lymphoblastic leukemia (ALL) in cases resistant or intolerant to prior therapy. It is also approved for pediatric patients aged one year and above with chronic-phase Ph+ CML.
According to IQVIA, Dasatinib tablets recorded a market size of approximately USD 1,017 million for the 12 months ending September 2025. With this approval, Alembic now holds a cumulative 227 ANDA approvals from the USFDA, including 207 final and 20 tentative approvals.
Alembic Pharmaceuticals is a vertically integrated R&D-driven company with a global footprint in generics, supported by manufacturing facilities accredited by major international regulators, including the USFDA.
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