usfda

US FDA updates warningfor Johnson & Johnson’s COVID-19 vaccine about rare neurological disorder

The US Food and Drug Administration updated its warning labels on Monday (Jul 12) for the Johnson & Johnson (J&J) COVID-19…

3 years ago

Bayer gets US FDA nod for KERENDIA (finerenone) to treat CKD associated with type 2 diabetes

Bayer announced the United States (US) Food and Drug Administration (FDA) has approved KERENDIA (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor…

3 years ago

Alembic Pharmaceuticals gets USFDA final nod for Erlotinib Tablets

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated…

3 years ago

Alembic Pharma gets USFDA final nod for Desipramine Hydrochloride Tablets USP

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated…

3 years ago

Alembic Pharma gets USFDA final approval for Nitrofurantoin Capsules, USP (Macrocrystals)

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated…

3 years ago

Glenmark gets USFDA nod for generic lung cancer drug

Glenmark Pharmaceuticals yesterday said it has received approval from the US health regulator to market Nintedanib capsules, used in the…

3 years ago

Glenmark receives ANDA tentative nod for Nintedanib Capsules, 100mg and 150 mg

Glenmark Pharmaceuticals Ltd has received tentative approval by the United States Food and Drug Administration (USFDA) for Nentenab Capsules, 100…

3 years ago

USFDA nod to Cipla’s inhalation product

Cipla yesterday said that it has received final approval from the US health regulator for Arformoterol Tartrate Inhalation Solution, used…

3 years ago

Dr Reddy’s Laboratories launches Icosapent Ethyl Capsules in US

Dr Reddy’s Laboratories yesterday launched Icosapent Ethyl capsules, used to reduce triglyceride (TG) levels in adult patients, in the US…

3 years ago

Mankind Pharma launches Justoza, a Dapagliflozin approved by USFDA

Mankind Pharma has launched Justoza, a Dapagliflozin brand marketed by Mankind to treat diabetes, heart failure and chronic kidney disease,…

3 years ago