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Results For "USFDA"

1205 News Found

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets
Drug Approval | December 23, 2022

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

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH


Alembic Pharmaceuticals receives PAS approval from USFDA for Pregabalin capsules
Drug Approval | December 23, 2022

Alembic Pharmaceuticals receives PAS approval from USFDA for Pregabalin capsules

Pregabalin Capsules have an estimated market size of US $244 million for twelve months ending Sep 2022 according to IQVIA


USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod
Drug Approval | December 20, 2022

USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod

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


Sun Pharmaceutical receives warning letter from USFDA for Halol facility
Drug Approval | December 19, 2022

Sun Pharmaceutical receives warning letter from USFDA for Halol facility

The Halol facility was placed under Import Alert by USFDA.


Alembic receives USFDA final Approval for Desonide Cream
Drug Approval | December 12, 2022

Alembic receives USFDA final Approval for Desonide Cream

Desonide Cream, 0.05%, has an estimated market size of US $12 million for twelve months ending Sep 2022 according to IQVIA


Zydus receives USFDA approval to market Silodosin and Pregabalin capsules
Drug Approval | December 12, 2022

Zydus receives USFDA approval to market Silodosin and Pregabalin capsules

Silodosin capsules treat signs and symptoms of an enlarged prostate gland


Zydus receives final approval from USFDA for Estradiol Transdermal System
Drug Approval | December 05, 2022

Zydus receives final approval from USFDA for Estradiol Transdermal System

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad


Alembic receives USFDA final approval for Diclofenac Sodium Topical Solution USP
Drug Approval | December 02, 2022

Alembic receives USFDA final approval for Diclofenac Sodium Topical Solution USP

Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US $512 million for twelve months ending Sep 2022 according to IQVIA


Zydus receives final approval from USFDA for Topiramate Extended-Release capsules
Drug Approval | December 02, 2022

Zydus receives final approval from USFDA for Topiramate Extended-Release capsules

Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)


JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets
Drug Approval | December 01, 2022

JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets

This product is based on Osmotic Controlled Release Oral Delivery System technology