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Results For "USFDA"

1404 News Found

USFDA conducts inspection at Glenmark's Aurangabad manufacturing facility
News | July 04, 2022

USFDA conducts inspection at Glenmark's Aurangabad manufacturing facility

The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.


Lupin receives approval from USFDA for Paliperidone extended-release tablets
Drug Approval | July 01, 2022

Lupin receives approval from USFDA for Paliperidone extended-release tablets

Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S


Zydus receives final approval from USFDA for Lacosamide injection
Drug Approval | July 01, 2022

Zydus receives final approval from USFDA for Lacosamide injection

Lacosamide Injection is used to treat partial-onset seizures.


Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant
Drug Approval | June 23, 2022

Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant

Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients


Glenmark Pharmaceuticals to address USFDA’s observation
News | June 23, 2022

Glenmark Pharmaceuticals to address USFDA’s observation

U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi


Alembic receives USFDA tentative approval for Dasatinib tablets
Drug Approval | June 12, 2022

Alembic receives USFDA tentative approval for Dasatinib tablets

Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive


Strides receives USFDA approval for Ibuprofen OTC oral suspension
Drug Approval | June 12, 2022

Strides receives USFDA approval for Ibuprofen OTC oral suspension

Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.


Sanofi Dupixent gets USFDA nod for atopic dermatitis
Drug Approval | June 10, 2022

Sanofi Dupixent gets USFDA nod for atopic dermatitis

Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood


Eugia Pharma receives USFDA Approval for Leuprolide Acetate Injection
Drug Approval | June 08, 2022

Eugia Pharma receives USFDA Approval for Leuprolide Acetate Injection

he approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.


Zydus Lifesciences receives USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel
Drug Approval | June 07, 2022

Zydus Lifesciences receives USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel

The drug will be manufactured at the group’s topical facility at Ahmedabad