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Tag: usfda

You Searched For "usfda"
USFDA nod to Lupin Iloperidone tablets

USFDA nod to Lupin Iloperidone tablets

Ruchika Sharma7 May 2022 12:36 PM IST
Mumbai: Lupin Limited has recently announced that the company has received approval from the United States Food and Drug Administration (USFDA) for...
Lupin gets USFDA nod for generic equivalent of Lyrica Capsules

Lupin gets USFDA nod for generic equivalent of Lyrica Capsules

Ruchika Sharma7 May 2022 11:25 AM IST
Pregabalin is used for the treatment of pain caused by nerve damage due to diabetes or shingles infection.
AstraZeneca, Daiichi Sankyo get USFDA nod for Enhertu for earlier breast cancer use

AstraZeneca, Daiichi Sankyo get USFDA nod for Enhertu for earlier breast cancer use

Ruchika Sharma6 May 2022 5:08 PM IST
The approval was granted under the FDA's Real-Time Oncology Review (RTOR) programme and converts the accelerated approval of Enhertu in later line...
Zydus Lifesciences gets USFDA nod for Pulmonary Arterial Hypertension drug Selexipag

Zydus Lifesciences gets USFDA nod for Pulmonary Arterial Hypertension drug Selexipag

Ruchika Sharma6 May 2022 3:03 PM IST
The drug will be manufactured at group’s formulation facility at SEZ, Ahmedabad.
Blood clot risk - USFDA limits use of JnJ COVID vaccine

Blood clot risk - USFDA limits use of JnJ COVID vaccine

Ruchika Sharma6 May 2022 12:54 PM IST
The vaccine maker said it has updated the U.S. COVID-19 vaccine fact sheet to warn about the risk of thrombosis with thrombocytopenia syndrome (TTS),...
USFDA nod to two Vonoprazan therapies for H. pylori infection eradication

USFDA nod to two Vonoprazan therapies for H. pylori infection eradication

Ruchika Sharma6 May 2022 12:06 PM IST
If left untreated, H. pylori infection can lead to serious complications, such as peptic ulcer disease and non-cardia gastric cancer.
Gland Pharma launches cancer drug Bortezomib in US

Gland Pharma launches cancer drug Bortezomib in US

Ruchika Sharma5 May 2022 12:06 PM IST
Hyderabad: Gland Pharma Limited, a generic injectable focused pharmaceutical company, through its partner has launched Bortezomib for Injection, 3.5 ...
Alembic Pharma arm gets USFDA nod for fever blisters cream Docosanol

Alembic Pharma arm gets USFDA nod for fever blisters cream Docosanol

Ruchika Sharma4 May 2022 12:37 PM IST
Docosanol Cream, 10% (OTC) is used for cold sore/fever blisters on the face or lips.
Bayer begins Phase I study with GIRK4 inhibitor for atrial fibrillation

Bayer gets USFDA priority review for darolutamide plus docetaxel to treat metastatic hormone-sensitive prostate cancer

Ruchika Sharma4 May 2022 12:00 PM IST
Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
Aurobindo Pharma arm bags USFDA nod for cancer drug Bortezomib

Aurobindo Pharma arm bags USFDA nod for cancer drug Bortezomib

Ruchika Sharma4 May 2022 11:00 AM IST
Hyderabad: Drugmaker, Aurobindo Pharma Limited, has recently announced that its wholly owned subsidiary company, Eugia Pharma Specialties...
Zydus Lifesciences bags USFDA nod for Bortezomib for Injection to treat cancer

Zydus Lifesciences bags USFDA nod for Bortezomib for Injection to treat cancer

Ruchika Sharma3 May 2022 3:26 PM IST
The drug will be manufactured at Zydus Hospira.
Shilpa Medicare gets 4 USFDA observations for Hyderabad division

Shilpa Medicare gets 4 USFDA observations for Hyderabad division

Ruchika Sharma2 May 2022 2:56 PM IST
Hyderabad: After a recent inspection, the U.S. Food and Drug Administration (USFDA) has issued four observations to Shilpa Medicare's recently...
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