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Results For "USFDA"

904 News Found

Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma
Drug Approval | July 14, 2024

Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma

The company will address these observations within the stipulated timeline


Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial
Drug Approval | July 14, 2024

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension


Lupin receives EIR from USFDA for its Dabhasa  facility
Drug Approval | July 13, 2024

Lupin receives EIR from USFDA for its Dabhasa facility

The facility is a part of Lupin Manufacturing Solutions


Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%
Drug Approval | July 10, 2024

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product


Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets
Drug Approval | July 10, 2024

Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan combination is used to treat chronic heart failure in adults


Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules
Drug Approval | July 10, 2024

Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules

Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis


Lupin receives tentative approval from USFDA for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets
Drug Approval | July 10, 2024

Lupin receives tentative approval from USFDA for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets

This product will be manufactured at Lupin’s Pithampur facility in India


Alembic Pharmaceuticals announces USFDA final approval for Doxycycline Capsules, 40 mg
Drug Approval | June 29, 2024

Alembic Pharmaceuticals announces USFDA final approval for Doxycycline Capsules, 40 mg

Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients