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Results For "United-States-Food-and-Drug-Administration"

417 News Found

Zydus receives final approval from USFDA for Acetaminophen injection
Drug Approval | October 30, 2022

Zydus receives final approval from USFDA for Acetaminophen injection

Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data


Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets
Drug Approval | October 27, 2022

Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets

Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.


Zydus receives final approval from USFDA for Micafungin for Injection
Drug Approval | October 26, 2022

Zydus receives final approval from USFDA for Micafungin for Injection

Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data


USFDA visit to Alembic Pharmaceuticals Panelav facility
Drug Approval | October 19, 2022

USFDA visit to Alembic Pharmaceuticals Panelav facility

None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable


Zydus receives tentative approval from USFDA for Roflumilast tablets
Drug Approval | October 18, 2022

Zydus receives tentative approval from USFDA for Roflumilast tablets

Roflumilast Tablets had annual sales of US $248 million in the United States according to IQVIA data


Zydus receives tentative approval from USFDA for Valbenazine capsules
Drug Approval | October 18, 2022

Zydus receives tentative approval from USFDA for Valbenazine capsules

Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data


ANDA approval from USFDA for Unichem's Extended Phenytoin Sodium Capsules
Drug Approval | October 15, 2022

ANDA approval from USFDA for Unichem's Extended Phenytoin Sodium Capsules

Extended Phenytoin Sodium Capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures


Zydus receives final approval from USFDA and 180 days shared exclusivity for Brivaracetam Tablets
Drug Approval | October 07, 2022

Zydus receives final approval from USFDA and 180 days shared exclusivity for Brivaracetam Tablets

Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.


Lupin receives approval from USFDA for Darunavir Tablets
Drug Approval | October 05, 2022

Lupin receives approval from USFDA for Darunavir Tablets

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


Zydus receives USFDA tentative approval for Amantadine Extended-Release capsules
Drug Approval | October 05, 2022

Zydus receives USFDA tentative approval for Amantadine Extended-Release capsules

Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data