Su­per­nus bat­tles back from CRL, scor­ing the FDA's ap­proval for non-stim­u­lant AD­HD med Qel­bree

Af­ter a harsh slap­down last fall, US reg­u­la­tors are now singing a dif­fer­ent tune on Su­per­nus Phar­ma­ceu­ti­cals’ “sprin­kleable” AD­HD drug.

The FDA on Fri­day ap­proved SPN-812 — now mar­ket­ed as Qel­bree — as a non-stim­u­lant treat­ment for AD­HD in kids 6 to 17 years old. And with new da­ta in hand for adult pa­tients, the com­pa­ny plans on fil­ing a sup­ple­men­tal NDA in the sec­ond half of this year.

Reg­u­la­tors ini­tial­ly re­ject­ed Su­per­nus’ ap­pli­ca­tion for Qel­bree back in No­vem­ber at the same time they is­sued an RTF for SPN-830, a con­tin­u­ous treat­ment pump meant for Parkin­son’s dis­ease.

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