Shire fi­nal­ly fin­ish­es a 10-year trek back to the FDA with an old AD­HD drug

A long 10 years af­ter the FDA first re­ject­ed Shire’s AD­HD drug SHP465, the biotech has fi­nal­ly got the ther­a­py back up in front of reg­u­la­tors. Shire said this morn­ing that the FDA has ac­knowl­edged re­ceiv­ing their ap­pli­ca­tion for the ther­a­py, which has the mod­est goal of ex­tend­ing a main­stay AD­HD drug’s reach from 12 hours to 16 hours.

That ex­tra 4 hours is enough to make SHP465 — which has the same ac­tive in­gre­di­ent as the now gener­ic Adder­all XR — a once-dai­ly pill, which is what drove the orig­i­nal sub­mis­sion back in 2006. And Shire is now set­ting the stage for a drug launch in the sec­ond half of this year.

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