1. Generics Bulletin

Viatris Target Rybelsus Among New FDA Product-Specific Guidances

Agency’s Running Total Of PSGs Approaches 2,000 Landmark

 
• By Dean Rudge

The latest tranche of product-specific guidances for generic development has been published by the US FDA, following two released in March and May this year.

US FDA entrance sign
The FDA has now published 1,921 PSGs • Source: Shutterstock

Boehringer Ingelheim’s Combivent Respimat (albuterol sulfate/ipratropium bromide) and Striverdi Respimat (olodaterol hydrochloride) inhalation sprays and Novo Nordisk’s Rybelsus (semaglutide) tablets are among 23 new product-specific guidances for generic drug development published by the US Food and Drug Administration, as part of the agency’s latest batch.

Alongside the new guidances are 16 revised product-specific guidances, including two for AbbVie’s Lupron Depot (leuprolide acetate) injectable – covering five new drug applications – as well as Bristol

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