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Results For "USFDA"

1404 News Found

Zydus receives final approval from the USFDA for Ivermectin Cream
Drug Approval | August 04, 2022

Zydus receives final approval from the USFDA for Ivermectin Cream

Ivermectin Cream is a used for the treatment of inflammatory lesions of rosacea.


Jubilant Pharmova gets 6 observations from USFDA for its facility at Roorkee
News | August 03, 2022

Jubilant Pharmova gets 6 observations from USFDA for its facility at Roorkee

he US FDA has issued six observations pursuant to the completion of the audit.


USFDA issues 3 observations for Aurobindo Pharma’s Unit XI
Drug Approval | August 03, 2022

USFDA issues 3 observations for Aurobindo Pharma’s Unit XI

The company has responded to the warning letter and carried out the committed corrections.


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.


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.


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).


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.


Zydus gets USFDA’s approval for Empagliflozin, Metformin Hydrochloride tablets
Drug Approval | July 12, 2022

Zydus gets USFDA’s approval for Empagliflozin, Metformin Hydrochloride tablets

Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.


Eugia Pharma receives USFDA approval for Triamcinolone Acetonide Injectable Suspension
Drug Approval | July 07, 2022

Eugia Pharma receives USFDA approval for Triamcinolone Acetonide Injectable Suspension

This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.