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605 News Found

Glenmark launches generic Lacosamide Injection USP in US Market
News | June 05, 2026

Glenmark launches generic Lacosamide Injection USP in US Market

Company expands injectable portfolio with therapeutically equivalent version of Vimpat®, targeting a market valued at approximately $15.2 million annually


Lupin and Natco get FDA approval for Eribulin Mesylate injection
Drug Approval | June 03, 2026

Lupin and Natco get FDA approval for Eribulin Mesylate injection

Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials is the bioequivalent to the reference listed drug (RLD) Halaven injection of Eisai, Inc.


Lupin wins FDA nod for generic colonoscopy prep drug with first-to-file exclusivity
Drug Approval | May 30, 2026

Lupin wins FDA nod for generic colonoscopy prep drug with first-to-file exclusivity

Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market


Lupin secures FDA nod for generic Sutab tablets with 180-day exclusivity
Drug Approval | May 30, 2026

Lupin secures FDA nod for generic Sutab tablets with 180-day exclusivity

The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals


ZIM Laboratories wins European regulatory milestone with anticoagulant approval in Italy
News | May 23, 2026

ZIM Laboratories wins European regulatory milestone with anticoagulant approval in Italy

The approval was granted by Agenzia Italiana del Farmaco


Alembic Pharma receives USFDA nod for generic Levothyroxine sodium tablets
Drug Approval | May 22, 2026

Alembic Pharma receives USFDA nod for generic Levothyroxine sodium tablets

Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism


Lupin gets tentative FDA nod for Revefenacin inhalation solution
Drug Approval | May 20, 2026

Lupin gets tentative FDA nod for Revefenacin inhalation solution

The drug is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)


Caplin Steriles receives USFDA approval for generic foscarnet sodium injection
Drug Approval | May 18, 2026

Caplin Steriles receives USFDA approval for generic foscarnet sodium injection

Antiviral injection addressing CMV and HSV infections had US market sales of nearly $15 million in the last 12 months


Glenmark Pharma introduces Vancomycin Injection in U.S. market
News | May 18, 2026

Glenmark Pharma introduces Vancomycin Injection in U.S. market

The product is bioequivalent and therapeutically equivalent to the reference listed drug by Fresenius Kabi USA, LLC.