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Corporate News
10-Jun-22
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Alembic Pharmaceuticals gets USFDA approval
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For Dasatinib Tablets
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Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol Myers Squibb Company (BMS). Dasatinib Tablet is indicated for the treatment of adult patients with i) newly diagnosed Philadelphia chromosome-positive (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.
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Previous News |
Alembic Pharmaceuticals consolidated net profit rises 2.41% in the September 2023 quarter
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Results
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Announcements
07-Nov-23
15:08
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Alembic Pharma's oncology formulation facility undergoes USFDA audit
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Corporate News
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09-Mar-24
12:26
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USFDA inspects Alembic Pharmaceuticals' Karkhadi unit
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Corporate News
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24-Mar-23
16:33
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Alembic Pharmaceuticals gets USFDA nod for hypertension drug
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29-Aug-22
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Alembic Pharma’s Gujarat facility gets 4 observations from USFDA
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Hot Pursuit
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09-Mar-24
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Alembic Pharmaceuticals receives USFDA approval for Lacosamide Tablets
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Corporate News
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21-Mar-22
15:17
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Alembic Pharma karkhadi facility gets two USFDA observations
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Hot Pursuit
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25-Mar-23
12:35
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Alembic Pharmaceuticals receives EIR for its Injectable Facility at Karkhadi
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Corporate News
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16-Feb-23
15:25
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Alembic Pharma gains as Karkhadi facility gets EIR from USFDA
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Hot Pursuit
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16-Feb-23
15:42
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Volumes soar at Lemon Tree Hotels Ltd counter
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Hot Pursuit
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02-Jan-24
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