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Results For "new-drug-application"

435 News Found

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


US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma
Drug Approval | September 12, 2021

US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma

Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma


Biocon settles suit with Celgene for generic Revlimid
Biotech | September 08, 2021

Biocon settles suit with Celgene for generic Revlimid

Revlimid is a blood cancer drug with sales of US $ 12.1 billion in 2020


Caplin Steriles gets US FDA approval for blood pressure injection
News | September 08, 2021

Caplin Steriles gets US FDA approval for blood pressure injection

Labetalol hydrochloride injection USP is indicated for the control of blood pressure in severe hypertension.


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)


Alembic JV Aleor receives US FDA final approval for skin disorder gel
Drug Approval | September 06, 2021

Alembic JV Aleor receives US FDA final approval for skin disorder gel

Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea


European Commission grants market authorisation for BioMarin’s Voxzogo
Biotech | August 28, 2021

European Commission grants market authorisation for BioMarin’s Voxzogo

It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo


Marksans announces US FDA approval for Acetaminophen Extended- Release tablets
News | August 27, 2021

Marksans announces US FDA approval for Acetaminophen Extended- Release tablets

The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India