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Results For "new-drug-application"

435 News Found

Lupin receives approval from USFDA for Brexpiprazole Tablets
Drug Approval | March 22, 2023

Lupin receives approval from USFDA for Brexpiprazole Tablets

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)


Caplin receives USFDA approval for Rocuronium Bromide Injection
Drug Approval | March 21, 2023

Caplin receives USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)


Phase 3 data show Deuruxolitinib significantly improve scalp hair regrowth in Alopecia Areata
News | March 20, 2023

Phase 3 data show Deuruxolitinib significantly improve scalp hair regrowth in Alopecia Areata

The Phase 3 data presented at AAD include a comprehensive review of the THRIVE-AA2 results and further elaborate the topline data reported in August 2022


Marksans Pharma announces USFDA approval for Famotidine Tablets
News | March 11, 2023

Marksans Pharma announces USFDA approval for Famotidine Tablets

Marksans' OTC Famotidine Tablets USP are acid reducers


Alembic receives USFDA final approval for Prazosin Hydrochloride Capsules
Drug Approval | March 09, 2023

Alembic receives USFDA final approval for Prazosin Hydrochloride Capsules

Prazosin Hydrochloride Capsule is indicated for the treatment of hypertension, to lower blood pressure


Caplin Steriles gets USFDA approval for Thiamine Hydrochloride Injection
Drug Approval | March 09, 2023

Caplin Steriles gets USFDA approval for Thiamine Hydrochloride Injection

Thiamine Hydrochloride Injection is effective in the treatment of vitamin B1 deficiency (beriberi)


Alembic Pharmaceuticals gets USFDA final approval for fluorouracil injection
Drug Approval | March 07, 2023

Alembic Pharmaceuticals gets USFDA final approval for fluorouracil injection

Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum and breast


Caplin Steriles gets USFDA approval for Rocuronium Bromide Injection
Drug Approval | March 04, 2023

Caplin Steriles gets USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection is a neuromuscular blocking agent


Merck and AstraZeneca updates on US regulatory review of Lynparza for mCRPC
News | March 03, 2023

Merck and AstraZeneca updates on US regulatory review of Lynparza for mCRPC

AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.