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Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg
08 Nov 2025 09:08 GMT
… ) for its Abbreviated New Drug Application (ANDA) Dasatinib Tablets … are indicated for the treatment of adult patients with: … to prior therapy including imatinib, (iii) Philadelphia chromosome … USFDA.
Shares of Alembic Pharmaceuticals Limited was last trading …
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<![CDATA[FDA Approves Abbreviated NDA for Dasatinib Tablets in Leukemia Indications]]>
08 Nov 2025 01:03 GMT
… FDA has issued final approval for an abbreviated new drug … Pharmaceuticals.1
Dasatinib tablets are currently indicated for the treatment … prior therapy, including imatinib (Gleevec)
Adult patients … randomized phase 3 DASISION trial (NCT00481247) randomly …
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<![CDATA[FDA Approves Generic Dasatinib Tablets for CML, ALL]]>
07 Nov 2025 17:32 GMT
… FDA has granted final approval to an abbreviated new drug … therapy, including imatinib (Gleevec).
for the treatment of adult … phase 2 CA180-372 trial (NCT01460160), which demonstrated … weight.
References
Alembic Pharmaceuticals Limited announces USFDA Final …
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Alembic Pharma receives US FDA final approval for dasatinib tablets
07 Nov 2025 12:11 GMT
… & Drug Administration (FDA) for its Abbreviated New Drug Application … are indicated for the treatment of adult patients with … to prior therapy including imatinib, (iii) Philadelphia … approvals) from US FDA.
Alembic Pharmaceuticals Limited, a vertically …
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Alembic Pharma bags USFDA nod for blood cancer drug Dasatinib
07 Nov 2025 11:26 GMT
… are indicated for the treatment of adult patients with … to prior therapy including imatinib,
(iii) Philadelphia chromosome … USFDA nod for anticonvulsant drug Carbamazepine Extended Release
… in India, Alembic Pharmaceuticals Limited is a vertically …
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Alembic Pharmaceuticals gets USFDA nod for generic blood cancer treatment drug
07 Nov 2025 10:14 GMT
… for the abbreviated new drug application (ANDA) of … are indicated for the treatment of adult patients with … to prior therapy including imatinib; and Philadelphia chromosome-positive … Citing IQVIA data, Alembic Pharmaceuticals said Dasatinib tablets, 20 …
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Alembic Pharmaceuticals receives USFDA final approval for Dasatinib Tablets across six strengths
07 Nov 2025 08:58 GMT
… ) for its Abbreviated New Drug Application (ANDA) for Dasatinib … is indicated for the treatment of Philadelphia chromosome-positive … prior therapy such as imatinib. It is also approved … and marketers of generic pharmaceuticals worldwide.
Disclaimer: The …
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<![CDATA[Imatinib Yields Durable Response, Survival Benefit in Advanced GIST]]>
03 Nov 2025 17:21 GMT
… BFR14 trial (NCT00367861) shared at the 2025 European Society of Medical Oncology … tumors treated with imatinib. The trial’s design compared imatinib interruption to its … standard first-line treatment for advanced GIST with imatinib-sensitive mutations, though …
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<![CDATA[Breaking Down the Evolving Treatment Landscape of GIST]]>
01 Nov 2025 21:45 GMT
… for Population Sciences, Harvard Medical School, Venkataraman shared insights … Yes! There are two trials that I think are probably … with Gleevec (imatinib) as the first-line treatment. But oftentimes, … of a large multicenter trial looking at Sutent versus …
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<![CDATA[New Directions in Treatment for Patients With GIST ]]>
30 Oct 2025 22:19 GMT
… Medical School.
Can you discuss emerging second- and third-line treatment … part of a large multicenter trial looking at Sutent (sunitinib … 1 trials looking at the combination of Gleevec (imatinib) and … are also in clinical trial.
Transcript has been edited …