Satsuma’s nasal migraine candidate rejected by FDA over CMC issues 

Sat­suma Phar­ma­ceu­ti­cals was hand­ed a com­plete re­sponse let­ter for its nasal mi­graine drug af­ter the agency found is­sues with the prod­uct’s chem­istry, man­u­fac­tur­ing and con­trols.

No is­sues were found re­lat­ed to the drug’s safe­ty, dubbed STS101, and no ad­di­tion­al clin­i­cal tri­als are need­ed, the com­pa­ny said Thurs­day. Sat­suma is in dis­cus­sions with the FDA and is con­sid­er­ing reap­ply­ing for an­oth­er new drug ap­proval for STS101.

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