Roche to re­file sub­cu­ta­neous Tecen­triq ap­pli­ca­tion with FDA be­fore year’s end on the back of man­u­fac­tur­ing tweaks

Roche plans to file a new ap­pli­ca­tion to the FDA by the end of the year for its sub­cu­ta­neous ver­sion of Tecen­triq, a spokesper­son told End­points News. The spokesper­son did not di­rect­ly an­swer whether Roche pulled its pre­vi­ous ap­pli­ca­tion or if its cur­rent ap­pli­ca­tion is still with the FDA, on­ly re­it­er­at­ing it in­tends to file a new ap­pli­ca­tion.

“We did not re­ceive a re­jec­tion (com­plete re­sponse let­ter or re­jec­tion to file). We are mak­ing these up­dates in line with the FDA re­quire­ments,” the spokesper­son not­ed.

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