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Results For "FDA"

2075 News Found

Strides receives USFDA approval for Cyclosporine Softgel Capsules
Drug Approval | August 03, 2022

Strides receives USFDA approval for Cyclosporine Softgel Capsules

Strides is the first Indian company to get approval for the product.


Casper Pharma completed USFDA pre-approval inspection
Drug Approval | July 31, 2022

Casper Pharma completed USFDA pre-approval inspection

The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.


Shilpa Medicare's Unit III, Advanced Analytical Characterization Laboratory clears US FDA remote record review
Drug Approval | July 31, 2022

Shilpa Medicare's Unit III, Advanced Analytical Characterization Laboratory clears US FDA remote record review

The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing


Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets
Drug Approval | July 26, 2022

Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.


Zydus receives final approval from the USFDA for Bisoprolol Fumarate Tablets
Drug Approval | July 26, 2022

Zydus receives final approval from the USFDA for Bisoprolol Fumarate Tablets

Bisoprolol Fumarate Tablets are used to treat high blood pressure.


FDA approval of deep brain stimulators will drive APAC market, says GlobalData
News | July 24, 2022

FDA approval of deep brain stimulators will drive APAC market, says GlobalData

Abbott has recently received the US Food and Drug Administration nod to use its DBS device for treatment-resistant depression


Roche's Elecsys Amyloid Plasma Panel granted FDA breakthrough device designation to enable a timely diagnosis of Alzheimer’s disease
News | July 20, 2022

Roche's Elecsys Amyloid Plasma Panel granted FDA breakthrough device designation to enable a timely diagnosis of Alzheimer’s disease

The Elecsys Amyloid Plasma Panel has the potential to ensure better identification of patients that require further confirmatory testing, supporting a more timely and accessible diagnosis.


Zydus receives final approval from the USFDA for Efinaconazole Topical Solution
Drug Approval | July 18, 2022

Zydus receives final approval from the USFDA for Efinaconazole Topical Solution

Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).


U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | July 15, 2022

U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.


USFDA removes Jubilant Generics' Olanzapine, Spironolactone and Valsartan from the excepted products list
Drug Approval | July 14, 2022

USFDA removes Jubilant Generics' Olanzapine, Spironolactone and Valsartan from the excepted products list

Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.