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Results For "approval"

2610 News Found

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


SMS Pharmaceuticals receives approval for Ibuprofen by EDQM
Drug Approval | July 24, 2022

SMS Pharmaceuticals receives approval for Ibuprofen by EDQM

With this, the company can start selling Ibuprofen in the European markets.


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).


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.


Cipla updates on US FDA product-specific pre-approval inspection
News | July 06, 2022

Cipla updates on US FDA product-specific pre-approval inspection

The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.


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.


India’s first mRNA vaccine from Gennova gets DCGI approval
Drug Approval | June 30, 2022

India’s first mRNA vaccine from Gennova gets DCGI approval

It is a two dose vaccine to be administered intramuscularly at 28 days apart


Cosentyx receives expanded approvals in EU for use in childhood arthritic conditions
Drug Approval | June 29, 2022

Cosentyx receives expanded approvals in EU for use in childhood arthritic conditions

Safety in these pediatric populations was consistent with the known safety profile across approved adult and pediatric indications1,2