Alembic Pharma bags USFDA nod for blood cancer drug Dasatinib
Vadodara: Alembic Pharmaceuticals Limited has announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.
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).
Dasatinib tablets are indicated for the treatment of adult patients with:
(i) newly diagnosed Philadelphia chromosomepositive (Ph+) chronic myeloid leukemia (CML) in chronic phase,
(ii) chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib,
(iii) Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
Dasatinib tablets are also indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase.
Read also: Alembic Pharma gets USFDA nod for anticonvulsant drug Carbamazepine Extended Release
Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, have an estimated market size of US$ 1,017 million for twelve months ending September 2025 according to IQVIA. Alembic has a cumulative total of 227 ANDA approvals (207 final approvals and 20 tentative approvals) from USFDA.
Read also: Alembic Pharma gets USFDA okay for Triamcinolone Acetonide Injectable Suspension
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.