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

378 News Found

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


Zydus receives final approval from USFDA for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg
Drug Approval | October 11, 2024

Zydus receives final approval from USFDA for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg

Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad


FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting


Briefs: NATCO Pharma, Mylan Pharmaceuticals, Novo Nordisk and Alembic Pharmaceuticals
News | October 09, 2024

Briefs: NATCO Pharma, Mylan Pharmaceuticals, Novo Nordisk and Alembic Pharmaceuticals

Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic


Zydus receives tentative approval from USFDA for Enzalutamide Tablets
Drug Approval | October 02, 2024

Zydus receives tentative approval from USFDA for Enzalutamide Tablets

Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad