Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Shire Receives FDA “Approvable” Letter On Adult Adderall Product

This article was originally published in The Pink Sheet Daily

Executive Summary

With an adult filing for Adderall replacement Vyvanse set for mid year, the company is weighing its options, Shire told “The Pink Sheet” DAILY.

You may also be interested in...



Shire Targets SHP465 ADHD Resubmission 10 Years After Initial Filing

Shire says it is on track to refile its long-shelved ADHD candidate SHP465 later this year after a Phase III trial in children and adolescents turned out positively.

Shire Finally Gets Resuscitated Adult ADHD Drug Back On Track With FDA

The 16-hour ADHD candidate SHP465 (SPD465) is being aimed at adults, but FDA wants a study in children, which will kick off in August and may allow a launch by the end of 2017, Shire says.

Shire Submits Vyvanse sNDA For Adult ADHD

The company plans to announce data from a Phase III trial in adults in the fourth quarter.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS066068

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel