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

377 News Found

Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg
Drug Approval | March 19, 2025

Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg

Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer


Lupin receives tentative approval from USFDA for Amifampridine Tablets
Drug Approval | March 18, 2025

Lupin receives tentative approval from USFDA for Amifampridine Tablets

Amifampridine Tablets, 10 mg are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.


Zydus receives final approval from USFDA for Eluxadoline Tablets, 75 mg and 100 mg
Drug Approval | March 17, 2025

Zydus receives final approval from USFDA for Eluxadoline Tablets, 75 mg and 100 mg

Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea


Zydus receives final approval from USFDA for Methenamine Hippurate Tablets USP, 1 gram
Drug Approval | March 13, 2025

Zydus receives final approval from USFDA for Methenamine Hippurate Tablets USP, 1 gram

Methenamine Hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections


UFlex secures USFDA approval for recycled PE in food packaging
Packaging | March 12, 2025

UFlex secures USFDA approval for recycled PE in food packaging

Announces Rs. 317 crore investment in new recycling plant


Zydus receives final approval from USFDA for Ketoconazole Shampoo, 2%
Drug Approval | March 10, 2025

Zydus receives final approval from USFDA for Ketoconazole Shampoo, 2%

Ketoconazole shampoo is an antifungal medication used to treat dandruff


Briefs: Alembic Pharma and IOL Chemicals and Pharmaceuticals
Drug Approval | March 07, 2025

Briefs: Alembic Pharma and IOL Chemicals and Pharmaceuticals

USFDA inspection at Alembic Pharma's Bioequivalence facility


Zydus receives final approval from USFDA for Dasatinib Tablets
Drug Approval | March 06, 2025

Zydus receives final approval from USFDA for Dasatinib Tablets

Dasatinib is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase


Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility
Drug Approval | March 05, 2025

Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility

The company will provide the necessary response on these observations to USFDA within stipulated 15 days


USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit
Drug Approval | February 27, 2025

USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

The observations issued are neither repeated observations nor related to data integrity