Mallinck­rodt chalks up CRL to pack­ag­ing and la­bel­ing fa­cil­i­ty strug­gles

Mallinck­rodt has been hand­ed a com­plete re­sponse let­ter in con­nec­tion to its NDA seek­ing ap­proval for ter­li­pressin, its drug to treat a rare kid­ney dis­ease.

The CRL comes as the Irish-Amer­i­can phar­ma scram­bled to find a new pack­ag­ing and la­bel­ing man­u­fac­tur­ing fa­cil­i­ty in the last two weeks, which meant that an in­spec­tion would not be com­plete by the PDU­FA date. An in­spec­tion is re­quired be­fore an NDA can be ap­proved. The phar­ma says that is the on­ly thing not­ed in the let­ter, and there “were no safe­ty or ef­fi­ca­cy is­sues cit­ed.”

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