Alembic Pharmaceuticals has received USFDA final approval for Dasatinib Tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. These tablets are therapeutically equivalent to Bristol-Myers Squibb’s Sprycel and are indicated for treating adult and pediatric patients with specific types of leukemia. The estimated market size for Dasatinib Tablets is US$ 1,017 million.
Dasatinib Tablets Approval
Alembic Pharmaceuticals Limited announced it has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets. The approval covers strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.
Therapeutic Equivalence and Indication
The approved ANDA is therapeutically equivalent to Bristol-Myers Squibb Company’s (BMS) Sprycel Tablets. Dasatinib tablets are prescribed for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase, or chronic, accelerated, myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance. It is also used for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. These tablets are also indicated for pediatric patients 1 year and older with Ph+ CML in chronic phase.
Market Size
Dasatinib Tablets in the strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, have an estimated market size of US$ 1,017 million for the twelve months ending September 2025, according to IQVIA.
Alembic’s USFDA Approvals
As of this announcement, Alembic Pharmaceuticals has a cumulative total of 227 ANDA approvals from the USFDA, which includes 207 final approvals and 20 tentative approvals.
Source: BSE
