Takeda's rare dis­ease drug's man­u­fac­tur­ing and sup­ply woes con­tin­ue as FDA re­jects sup­ple­ment

Al­most 3 years af­ter Take­da had to re­call a drug that can help peo­ple with the rare con­di­tion known as hy­poparathy­roidism, those wait­ing for any sign that sup­plies of their re­li­able in­jec­tion from Take­da might reemerge will have to wait even longer.

Take­da an­nounced on Tues­day that the FDA re­ject­ed its Pri­or Ap­proval Sup­ple­ment (PAS) sub­mit­ted last Au­gust to ad­dress the for­ma­tion of rub­ber par­tic­u­lates that led to the ini­tial re­call in Sep­tem­ber 2019.

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