 |
Corporate News
10-Jun-22
|
|
|
|
|
|
|
|
|
|
|
|
Alembic Pharmaceuticals gets USFDA approval
|
|
For Dasatinib Tablets
|
|
|
|
|
|
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.
|
|
|
|
Previous News |
Volumes soar at Alembic Pharmaceuticals Ltd counter
(
Hot Pursuit
-
30-Nov-23
14:30
)
|
|
|
Alembic Pharma's Panelav unit successfully completes USFDA inspection
(
Corporate News
-
26-Jul-24
13:36
)
|
|
|
Alembic Pharma gains after receiving US FDA nod for psoriasis treatment drug Acitretin
(
Hot Pursuit
-
07-Aug-24
13:12
)
|
|
|
Alembic Pharma gains after receiving USFDA nod for Betamethasone Valerate Foam
(
Hot Pursuit
-
26-Aug-24
09:55
)
|
|
|
USFDA inspects Alembic Pharmaceuticals' Karkhadi unit
(
Corporate News
-
24-Mar-23
16:33
)
|
|
|
Alembic Pharmaceuticals to hold AGM
(
Corporate News
-
22-Jun-24
17:42
)
|
|
|
Alembic Pharma gets US FDA nod for antihistamine Alcaftadine ophthalmic solution
(
Hot Pursuit
-
04-Oct-24
09:29
)
|
|
|
Alembic Pharma Q2 PAT falls 19% YoY; R&D spend at Rs 168 crore
(
Hot Pursuit
-
11-Nov-22
14:21
)
|
|
|
Alembic Pharma karkhadi facility gets two USFDA observations
(
Hot Pursuit
-
25-Mar-23
12:35
)
|
|
|
Alembic Pharma reports turnaround Q1 numbers
(
Hot Pursuit
-
05-Aug-23
12:56
)
|
|
|
Camlin Fine Sciences Ltd leads gainers in 'A' group
(
Hot Pursuit
-
30-Nov-23
12:00
)
|
|
|
|
|
|
Other Stories |
|
|
|
|
|
|
|
|
|
|
|
|
|