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Results For "United-States-Food-and-Drug-Administration"

432 News Found

Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP
Drug Approval | December 20, 2024

Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP

Lidocaine and Prilocaine cream had annual sales of US $22.05 million in the United States (IQVIA MAT October 2024)


Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion
Drug Approval | December 17, 2024

Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion

Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery


Gland Pharma receives approval for phytonadione injection emulsion
Drug Approval | December 12, 2024

Gland Pharma receives approval for phytonadione injection emulsion

This product is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.


Lupin receives tentative approval from USFDA for Abacavir, Dolutegravir and Lamivudine tablets for oral suspension
Drug Approval | December 09, 2024

Lupin receives tentative approval from USFDA for Abacavir, Dolutegravir and Lamivudine tablets for oral suspension

The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen


Lupin gets tentative approval from USFDA for Sitagliptin and Metformin Hydrochloride Tablets
Drug Approval | December 05, 2024

Lupin gets tentative approval from USFDA for Sitagliptin and Metformin Hydrochloride Tablets

Sitagliptin and Metformin Hydrochloride Tablets, 50 mg/500 mg and 50 mg/1000 mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus


Gland Pharma receives approval for Latanoprost Opthalmic Solution, 0.005%
Drug Approval | December 04, 2024

Gland Pharma receives approval for Latanoprost Opthalmic Solution, 0.005%

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xalatan


Dr. Reddy's launches Toripalimab in India
News | December 01, 2024

Dr. Reddy's launches Toripalimab in India

The first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma


Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules
Drug Approval | November 20, 2024

Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules

The product will be manufactured at Lupin’s Somerset facility in the US


Lupin receives tentative approval from USFDA for Raltegravir Tablets
Drug Approval | November 09, 2024

Lupin receives tentative approval from USFDA for Raltegravir Tablets

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


Zydus receives final approval from USFDA for Fludrocortisone Acetate Tablets USP, 0.1 mg
Drug Approval | October 19, 2024

Zydus receives final approval from USFDA for Fludrocortisone Acetate Tablets USP, 0.1 mg

Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad