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Results For "New-Drug-Application"

410 News Found

Lupin receives FDA approval Rivaroxaban for oral suspension
Drug Approval | October 01, 2025

Lupin receives FDA approval Rivaroxaban for oral suspension

The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India


Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections
Drug Approval | October 01, 2025

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company


AbbVie submits application to FDA for Tavapadon for treatment of Parkinson's disease
Drug Approval | September 29, 2025

AbbVie submits application to FDA for Tavapadon for treatment of Parkinson's disease

If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once daily oral treatment option


FDA approves Alembic’s Paroxetine ER tablets
Drug Approval | September 26, 2025

FDA approves Alembic’s Paroxetine ER tablets

Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of major depressive disorder


Lupin receives FDA tentative approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets
Drug Approval | September 25, 2025

Lupin receives FDA tentative approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg


Novo Nordisk’s Wegovy delivered 16.6% weight loss
News | September 18, 2025

Novo Nordisk’s Wegovy delivered 16.6% weight loss

Wegovy achieved significant weight loss with one in three study participants losing 20% or more body weight


FDA approves Lupin’s Lenalidomide capsules
Drug Approval | September 17, 2025

FDA approves Lupin’s Lenalidomide capsules

Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma


Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market
News | September 05, 2025

Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market

Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product


Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
Drug Approval | September 04, 2025

Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity

This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity