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Results For "USFDA"

1134 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.


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.


USFDA conducts inspection at Glenmark's Aurangabad manufacturing facility
News | July 04, 2022

USFDA conducts inspection at Glenmark's Aurangabad manufacturing facility

The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.


Lupin receives approval from USFDA for Paliperidone extended-release tablets
Drug Approval | July 01, 2022

Lupin receives approval from USFDA for Paliperidone extended-release tablets

Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 152 million in the U.S


Zydus receives final approval from USFDA for Lacosamide injection
Drug Approval | July 01, 2022

Zydus receives final approval from USFDA for Lacosamide injection

Lacosamide Injection is used to treat partial-onset seizures.