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Results For "United-States"

845 News Found

Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP
Drug Approval | July 23, 2024

Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP

Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension


Briefs: Zydus Lifesciences and Divi's Laboratories
Drug Approval | July 22, 2024

Briefs: Zydus Lifesciences and Divi's Laboratories

Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets


Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval
Drug Approval | July 22, 2024

Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval

Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well


New data for Roche’s Susvimo demonstrates sustained efficacy in two serious diabetic eye conditions
Diagnostic Center | July 22, 2024

New data for Roche’s Susvimo demonstrates sustained efficacy in two serious diabetic eye conditions

Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant


Lupin’s partner ForDoz receives USFDA approval for doxorubicin hydrochloride liposome injection
Drug Approval | July 22, 2024

Lupin’s partner ForDoz receives USFDA approval for doxorubicin hydrochloride liposome injection

Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)


Unichem gets 5 observations from USFDA for Goa formulation facility
Drug Approval | July 17, 2024

Unichem gets 5 observations from USFDA for Goa formulation facility

The inspection closed with five observations which were more of procedural changes with none of these related to data integrity


Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma
Drug Approval | July 14, 2024

Suven Pharmaceuticals gets Form 483 from with two observations from USFDA for Casper Pharma

The company will address these observations within the stipulated timeline


Lupin receives EIR from USFDA for its Dabhasa  facility
Drug Approval | July 13, 2024

Lupin receives EIR from USFDA for its Dabhasa facility

The facility is a part of Lupin Manufacturing Solutions


Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets
Drug Approval | July 10, 2024

Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan combination is used to treat chronic heart failure in adults


Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules
Drug Approval | July 10, 2024

Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules

Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis