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Results For "approval"

2609 News Found

Zydus receives final approval from the USFDA for Isoproterenol Hydrochloride Injection
Drug Approval | April 17, 2023

Zydus receives final approval from the USFDA for Isoproterenol Hydrochloride Injection

Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output


Zydus receives final approval from USFDA for Tavaborole Topical Solution
Drug Approval | April 12, 2023

Zydus receives final approval from USFDA for Tavaborole Topical Solution

Tavaborole Topical Solution, 5% had annual sales of US $3.1 million in the United States


Zydus receives final approval from the USFDA for Azithromycin Tablets
Drug Approval | April 11, 2023

Zydus receives final approval from the USFDA for Azithromycin Tablets

Azithromycin Tablets USP, 500 mg had annual sales of US $20 million in the United States


Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug
Drug Approval | April 11, 2023

Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug

Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.


Inflation and declining FDA drug approvals will pose challenges for pharma contract manufacturers in 2023, says GlobalData
News | April 08, 2023

Inflation and declining FDA drug approvals will pose challenges for pharma contract manufacturers in 2023, says GlobalData

FDA’s NME approvals declined substantially in 2022, causing overall New Drug Application (NDA) approvals to drop


Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets
Drug Approval | April 07, 2023

Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets

Carbidopa and Levodopa is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms


Zydus receives final approval from the USFDA for Acetazolamide Tablets
Drug Approval | April 07, 2023

Zydus receives final approval from the USFDA for Acetazolamide Tablets

Acetazolamide is used to treat glaucoma


Alembic receives USFDA final approval for Brimonidine Tartrate Ophthalmic Solution
Drug Approval | March 31, 2023

Alembic receives USFDA final approval for Brimonidine Tartrate Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure


Granules India receives ANDA approval for Gabapentin Tablets
Drug Approval | March 30, 2023

Granules India receives ANDA approval for Gabapentin Tablets

Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults


Zydus receives final approval from USFDA for Loperamide Hydrochloride Capsules
Drug Approval | March 29, 2023

Zydus receives final approval from USFDA for Loperamide Hydrochloride Capsules

Loperamide Hydrochloride Capsules USP, 2 mg had annual sales of US $34.7 million in the United States