1. Generics Bulletin

FDA’s New PSG Batch Features GSK’s Inhalers

New Guidance Documents Issued on HIV, ALS, Oncology, And Opioid Overdose Generics

 
• By Urtė Fultinavičiūtė

In its latest batch of product-specific guidances, the FDA released multiple new and revised guidances on inhalers, including several on GSK’s products such as Relenza and the Ellipta trio.

FDA US Food and Drug website in browser with company logo
The latest release had 62 PSGs • Source: Shutterstock

The US Food and Drug Administration has released a new batch of product-specific guidances, which included the revision of guidelines for developing generic versions of several GSK's powder inhalers, as well as Novartis and Sanofi’s oncology drugs.

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