Generics Bulletin

FDA’s Latest PSGs Include Wegovy Generics

New Generic Development Guidance Documents Also Cover Duobrii And Radicava ORS

22 Nov 2023

A fresh batch of product-specific guidances to aid generics development has been published by the US Food and Drug Administration, including new documents covering Wegovy, Duobrii and Radicava ORS, as well as revised PSGs for Celestone Soluspan and Gralise.

Sign outside of FDA's headquarters in White Oak, MD — The FDA has published a fresh batch of product-specific guidances • Source: Alamy

Wegovy (semaglutide subcutaneous solution), Duobrii (halobetasol propionate/tazarotene lotion) and Radicava ORS (edaravone oral suspension) are among the brands covered by new product-specific guidances for generic development that have just been issued by the US Food and Drug Administration.

The FDA publishes PSGs to help facilitate generic drug development by providing recommendations for developing generic drugs and generating evidence...