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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 |
Board of Alembic Pharmaceuticals recommends final dividend
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06-May-23
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Alembic Pharmaceuticals consolidated net profit rises 596.17% in the March 2023 quarter
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Results
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Announcements
05-May-23
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Alembic Pharma reports turnaround Q1 numbers
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05-Aug-23
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Alembic Pharma get US FDA nod for acne topical gel
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Alembic receives USFDA approval for Diclofenac Sodium Topical Solution
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01-Dec-22
11:17
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Board of Alembic Pharmaceuticals recommends Final Dividend
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Corporate News
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05-May-23
17:26
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Alembic Pharma gets USFDA nod for Entacapone tablets
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Hot Pursuit
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06-Jan-22
14:02
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Alembic Pharmaceuticals receives USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel
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Corporate News
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08-Aug-22
11:04
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Alembic Pharma's Panelav facility gets EIR from USFDA
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Hot Pursuit
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09-Dec-22
14:23
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Board of Alembic Pharmaceuticals appoints director
(
Corporate News
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10-Feb-22
16:43
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USFDA issues EIR for Alembic's Panelav oncology injectable formulation unit
(
Corporate News
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09-Dec-22
13:39
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