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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 Pharmaceuticals receives USFDA approval (final & tentative) for 11 products
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Corporate News
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03-Jul-24
15:42
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Alembic Pharma gets USFDA nod for Docetaxel injection
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01-Mar-23
11:59
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Alembic Pharmaceuticals receives USFDA approval for various products
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Corporate News
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09-May-24
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Alembic Pharma jumps on USFDA nod for glaucoma drug
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Hot Pursuit
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31-Mar-23
10:10
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Alembic Pharma gets USFDA nod for hypertension drug
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Hot Pursuit
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30-Mar-23
14:08
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Alembic Pharmaceuticals to convene board meeting
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Corporate News
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18-Jan-23
10:51
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Alembic Pharma gets PAS nod from USFDA for pregabalin capsules
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Hot Pursuit
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22-Dec-22
14:57
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Alembic Pharma slips as US FDA issues Form 483 to Panelav facility
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Hot Pursuit
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18-Oct-22
11:50
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Alembic Pharmaceuticals receives USFDA approval for Mesalamine ER Capsules
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Corporate News
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02-Nov-22
09:40
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Alembic Pharma rises after receiving tentative approval for anti anginal drug
(
Hot Pursuit
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20-Apr-22
11:30
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