Alembic Pharmaceuticals Gains USFDA Approval for Dasatinib Tablets
Filing Summary
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Dasatinib Tablets in various strengths, including 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. These tablets are therapeutically equivalent to the reference listed drug, Sprycel Tablets, by Bristol-Myers Squibb Company. The market size for Dasatinib Tablets is estimated at USD 1,017 million for the twelve months ending September 2025. Alembic has a cumulative total of 227 ANDA approvals from the USFDA.
Alembic Pharmaceuticals Limited has announced the receipt of final approval from the US Food & 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. This approval confirms the therapeutic equivalence of Alembic’s Dasatinib Tablets to the reference listed drug, Sprycel Tablets, manufactured by Bristol-Myers Squibb Company.
The approved Dasatinib Tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, as well as chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib. Additionally, they are indicated for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. The tablets are also approved for pediatric patients aged one year and older with Ph+ CML in chronic phase.
The estimated market size for Dasatinib Tablets is USD 1,017 million for the twelve months ending September 2025, according to IQVIA data. This approval adds to Alembic’s cumulative total of 227 ANDA approvals from the USFDA, which includes 207 final approvals and 20 tentative approvals.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It focuses on manufacturing and marketing generic pharmaceutical products globally. Alembic’s research and manufacturing facilities are approved by regulatory authorities in several developed countries, including the USFDA. The company is recognized as a leader in branded generics in India.