Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Vyvanse’s Long Shadow: Launch To Decide Fate Of Two Other Shire NDAs

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Shire is keeping two pending NDAs for new attention deficit hyperactivity disorder treatments in a sort of limbo while it waits to see if the high expectations for the launch of its d-amphetamine prodrug Vyvanse are fulfilled

You may also be interested in...



Shire submits Connexyn for ADHD

Shire submitted an NDA Aug. 24 for its attention deficit/hyperactivity disorder compound SPD503 (guanfacine) with the proposed trade name Connexyn. If approved, the drug would be the second non-stimulant product in its category. The company submitted another ADHD drug in July - SPD465 - designed to provide sustained release of medication for 16 hours. SPD465 has a May 21, 2007 standard review user fee date for treatment of adult ADHD; the agent has the same active ingredient as Shire's established Adderall brand (1Pharmaceutical Approvals Monthly August 2006, In Brief)...

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

Gene Therapy Approvals By US FDA Could Double In 2020

CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.

UsernamePublicRestriction

Register

PS003598

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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