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Tag: usfda

You Searched For "usfda"
Lupin schizophrenia drug Aripiprazole gets USFDA okay

Lupin schizophrenia drug Aripiprazole gets USFDA okay

Ruchika Sharma20 March 2024 1:30 PM IST
Aripiprazole Tablets USP are indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I...
JnJ backed HistoSonics explores sale at USD 2.5 billion valuation: Report

USFDA nod to Johnson and Johnson EDURANT PED for certain pediatric patients living with HIV-1

Ruchika Sharma20 March 2024 12:30 PM IST
Titusville: Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved EDURANT PED (rilpivirine) for the...
Alembic Pharma secures USFDA final nod for anticonvulsant drug Carbamazepine

Aurobindo Pharma bags USFDA nod for Mometasone Furoate Monohydrate Nasal Spray

Ruchika Sharma20 March 2024 11:09 AM IST
Mometasone Furoate Monohydrate Nasal Spray, 50 mcg/spray, is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial...
FDA

FDA Approves First Gene Therapy for rare genetic disease affecting brain and nervous system in kids

Dr. Kamal Kant Kohli19 March 2024 3:00 AM IST
The U.S. Food and Drug Administration has approved first Gene Therapy for rare genetic disease affecting brain and nervous system in kids.Lenmeldy...
Lupin unveils pregnancy prevention drug Minzoya in US

Lupin gets one USFDA observation for Aurangabad facility

Ruchika Sharma18 March 2024 12:20 PM IST
Mumbai: Lupin has announced that the Company received Form-483 with one observation from the US Food and Drug Administration (USFDA) at the...
Aurobindo Pharma gets USFDA final, tentative nod for different strengths of deep vein thrombosis drug Rivaroxaban

Zydus Lifesciences gets USFDA okay for Finasteride and Tadalafil Capsules

Susmita Roy18 March 2024 11:52 AM IST
Tadalafil is used to treat benign prostatic hyperplasia.
USFDA nod to Ipratropium Bromide Nasal Solution

Lupin gets USFDA nod to market a generic drug to treat bacterial infections

Kajal Rajput16 March 2024 2:28 PM IST
Drug maker Lupin said it has received approval from the US health regulator to market a generic medication to treat bacterial infections, in...
Semaglutide-Metformin Combo Beneficial for Patients with T2DM and NAFLD

FDA Approves First Treatment for Patients with Liver scarring Due to NASH

Dr. Kamal Kant Kohli15 March 2024 10:30 PM IST
The U.S. Food and Drug Administration has approved Rezdiffra (resmetirom) for treatment of adults with noncirrhotic non-alcoholic steatohepatitis...
Alembic Pharma secures USFDA final nod for anticonvulsant drug Carbamazepine

Bristol Myers Squibb gets USFDA accelerated nod for Breyanzi as CAR T Cell Therapy for adults with relapsed or refractory chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Susmita Roy15 March 2024 12:32 PM IST
Princeton: Bristol Myers Squibb has announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of...
Zydus Lifesciences gets USFDA nod for Glatiramer Acetate Injection for relapsing forms of Multiple Sclerosis

Zydus Lifesciences bags USFDA tentative nod for Edaravone Injection to treat amyotrophic lateral sclerosis

Susmita Roy15 March 2024 11:49 AM IST
Edaravone is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis.
Hospital Inspection

Zydus Lifesciences wins USFDA nod for Chlorpromazine Hydrochloride Injection for certain mental disorders

Susmita Roy14 March 2024 4:00 PM IST
The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara (India).
JnJ backed HistoSonics explores sale at USD 2.5 billion valuation: Report

Johnson & Johnson seeks USFDA nod for Tremfya for ulcerative colitis treatment in adults

Ruchika Sharma12 March 2024 12:39 PM IST
Spring House: Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug...
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