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Results For "new-drug-application"

435 News Found

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


EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints


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


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


Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)
Drug Approval | November 30, 2022

Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)

Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection.


Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US
News | November 24, 2022

Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US

Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)


Alembic receives USFDA final approval for Nifedipine Extended-Release Tablets
Drug Approval | November 22, 2022

Alembic receives USFDA final approval for Nifedipine Extended-Release Tablets

Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022


Alembic receives USFDA final approval for Cyclophosphamide Capsules
Drug Approval | November 14, 2022

Alembic receives USFDA final approval for Cyclophosphamide Capsules

Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.


YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine
Drug Approval | November 11, 2022

YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine

PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.


Lupin receives tentative approval from USFDA for Doxycycline Capsules
Drug Approval | November 09, 2022

Lupin receives tentative approval from USFDA for Doxycycline Capsules

Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US