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Results For "tentative-approval"

257 News Found

Alembic receives USFDA tentative approval for hypertension drug
Drug Approval | March 14, 2022

Alembic receives USFDA tentative approval for hypertension drug

Macitentan tablets, 10 mg have an estimated market size of US $ 797 million for twelve months ending Dec 2021 according to IQVIA


Alembic receives USFDA tentative approval for fesoterodine fumarate
Drug Approval | February 02, 2022

Alembic receives USFDA tentative approval for fesoterodine fumarate

The tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency


Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection
Drug Approval | January 17, 2022

Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection

The company has 47 ANDA's pending approval with the U.S.FDA


Zydus Pharmaceuticals USA receives tentative approval for schizophrenia drug
Drug Approval | December 11, 2021

Zydus Pharmaceuticals USA receives tentative approval for schizophrenia drug

The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.


Gland Pharma receives tentative approval for Cangrelor
Drug Approval | December 09, 2021

Gland Pharma receives tentative approval for Cangrelor

Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity


Zydus Cadila receives tentative approval for IBS tablets
Drug Approval | November 15, 2021

Zydus Cadila receives tentative approval for IBS tablets

The group now has 324 approvals and has so far filed over 400 ANDAs


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


Zydus Cadila’s Sitagliptin base tablets receive tentative approval from US FDA
Drug Approval | September 06, 2021

Zydus Cadila’s Sitagliptin base tablets receive tentative approval from US FDA

Zydus’ Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (Sitagliptin Phosphate)


Zydus Cadila receives tentative approval for cancer drug
News | August 17, 2021

Zydus Cadila receives tentative approval for cancer drug

Lenalidomide is used to treat cancer and also some anaemia disorders


Unichem receives tentative approval for ANDA of Sitagliptin tablets
News | July 11, 2021

Unichem receives tentative approval for ANDA of Sitagliptin tablets

Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus