On December 20, 2024, the US Court of Appeals for the Federal Circuit released its opinion in Teva Branded Pharm. Prods. R&D, Inc. v. Amneal ...

This small manufacturing pharma concern is focused on making and distributing generic and proprietary injectable, inhalation, and intranasal products. These developments in recent years have led ...

Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA), ...

Patentees and sponsors of New Drug Applications ... HFA Inhalation Aerosol product, which permits Teva to market and sell an inhaler device that administers the API albuterol sulfate.

THURSDAY, Dec. 26, (2024 HealthDay News) -- The U.S. Food and Drug Administration (FDA) announced on Monday the approval of the first generic version of a daily injectable GLP-1 medicine for ...

In a move that could eventually make weight loss drugs cheaper and easier to access, the Food and Drug Administration Monday approved a second generic in the category of medications known as GLP-1s.

Dec 23 (Reuters) - The U.S. Food and Drug Administration on Monday approved Hikma Pharmaceuticals' (HIK.L), opens new tab generic version of Novo Nordisk's diabetes drug (NOVOb.CO), opens new tab ...

Although a higher-than-normal propellant-leak rate can result in increased drug and excipient composition ... for both MDIs is 108 µg of albuterol sulfate, which corresponds to 90 µg of ...