Af­ter de­lay caused by Ital­ian CD­MO, No­var­tis moves man­u­fac­tur­ing to Aus­tri­an site

Af­ter the FDA hand­ed No­var­tis a com­plete re­sponse let­ter for its PC­SK9 drug in­clisir­an in De­cem­ber due to man­u­fac­tur­ing de­fi­cien­cies with its Ital­ian CD­MO part­ner, the com­pa­ny has re­sub­mit­ted its ap­pli­ca­tion af­ter switch­ing to its own man­u­fac­tur­ing site in Schafte­nau, Aus­tria.

The site in Schafte­nau will start pro­duc­tion fol­low­ing FDA in­spec­tion, which is ex­pect­ed “in due course,” a spokesper­son from No­var­tis said in an email to End­points News.

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