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

417 News Found

Zydus receives tentative approval from USFDA for Letermovir Tablets
Drug Approval | March 23, 2024

Zydus receives tentative approval from USFDA for Letermovir Tablets

Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)


Zydus receives USFDA approval for Finasteride and Tadalafil capsules
Drug Approval | March 18, 2024

Zydus receives USFDA approval for Finasteride and Tadalafil capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India


Zydus receives USFDA final approval for chlorpromazine hydrochloride injection
Drug Approval | March 14, 2024

Zydus receives USFDA final approval for chlorpromazine hydrochloride injection

Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders


USFDA conducts inspection at Alembic Pharmaceuticals' Panelav oncology formulation facility
Drug Approval | March 09, 2024

USFDA conducts inspection at Alembic Pharmaceuticals' Panelav oncology formulation facility

The company will provide comprehensive response to USFDA for the observations


Cipla incorporates JV company in USA
News | March 02, 2024

Cipla incorporates JV company in USA

Cipla completes transfer of Generics Business Undertaking


Briefs: Eugia Pharma Specialities and Eugia SEZ
News | March 01, 2024

Briefs: Eugia Pharma Specialities and Eugia SEZ

Eugia Pharma Specialities restarts production at terminally sterilized product lines


Orchid Pharma's 'Exblifep' receives USFDA approval
Drug Approval | February 24, 2024

Orchid Pharma's 'Exblifep' receives USFDA approval

Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA


Lupin receives approval from USFDA for Minzoya
Drug Approval | February 17, 2024

Lupin receives approval from USFDA for Minzoya

Minzoya Tablets are indicated for use by females of reproductive potential to prevent pregnancy


Zydus receives USFDA approval for Isosorbide Mononitrate Extended-Release, Tablets USP
Drug Approval | February 17, 2024

Zydus receives USFDA approval for Isosorbide Mononitrate Extended-Release, Tablets USP

Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease)


Lupin launches Ganirelix Acetate Injection in US
News | February 16, 2024

Lupin launches Ganirelix Acetate Injection in US

It is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation