Guidance aligns with USP Chapters <790> and <1790>; encourages risk-based approach to identifying and correcting particulate contamination of sterile injectables to build on recent successes in reducing particulate-driven recalls.

Viatris may be able to move earlier than anticipated with its Breyna proposed generic version of Symbicort, after the US Court of Appeals for the Federal Circuit found that a lower court had misinterpreted claims of Symbicort patents for which Viatris has stipulated to infringement.

After over two years of litigation, Vifor and American Regent have reached agreements with Viatris’ Mylan and Sandoz regarding their generic ferric carboxymaltose products, allowing both companies to bring rivals to market ahead of the expiry of certain US patents.

The agency offers ‘regulatory flexibility’ for certain requirements of the iPLEDGE REMS for the acne drug if manufacturers address delays in implementing the modified program.