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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