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Results For "New-Drug-Application"

372 News Found

Alembic JV receives final approval for Mupirocin cream
Drug Approval | November 17, 2021

Alembic JV receives final approval for Mupirocin cream

The cream has an estimated market size of US $ 28 million for twelve months ending Jun 2021 according to IQVIA


U.S. FDA approves ANI’s purified cortrophin gel
Biotech | November 03, 2021

U.S. FDA approves ANI’s purified cortrophin gel

Cortrophin gel is purified corticotropin (ACTH), an important treatment option for patients struggling with certain chronic autoimmune disorders. It acquired the NDA for cortrophin gel from Merck & Co. in 2016


Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial
Biotech | October 28, 2021

Ocugen submits IND application with U.S. FDA for Covaxin phase 3 trial

The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population


Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules
Drug Approval | October 19, 2021

Dr Reddy’s Labs announces U.S. FDA approval for Lenalidomide capsules

The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg


Granules gets ANDA approval for Dofetilide capsules
Drug Approval | October 18, 2021

Granules gets ANDA approval for Dofetilide capsules

The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm


Exelixis in-licenses second anti-cancer compound from Aurigene
Biotech | October 15, 2021

Exelixis in-licenses second anti-cancer compound from Aurigene

U.S. FDA has accepted the investigational new drug application for phase 1 clinical trial in non-Hodgkin’s lymphoma


Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis
Biotech | October 09, 2021

Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis

The rolling submission to the U.S. FDA will begin in the fourth quarter of this year


Lupin receives tentative approval for Brexpiprazole tablets
Drug Approval | October 06, 2021

Lupin receives tentative approval for Brexpiprazole tablets

This product will be manufactured at Lupin’s Pithampur facility In India


Natco announces launch of 10 mg Everolimus in the US
Drug Approval | October 01, 2021

Natco announces launch of 10 mg Everolimus in the US

According to industry sales data, the 10mg strength of Afinitor generated annual sales of US $ 392 million during the twelve months ending July 2021


HUTCHMED initiates a Japan bridging study to Support Surufatinib
Biotech | September 21, 2021

HUTCHMED initiates a Japan bridging study to Support Surufatinib

Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan