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


Novartis Focalin XR Extended-Release ADHD Therapy Will Launch In June

This article was originally published in The Pink Sheet Daily

Executive Summary

The May 26 Focalin XR approval marks Novartis’ first ADHD treatment indication in adults. The NDA was supported by two clinical trials, one in adults and one in children.

You may also be interested in...

Teva Generic Versions Of Focalin Clear FDA With 180-Day Exclusivity

The approval includes 2.5 mg, 5 mg and 10 mg formulations of dexmethylphenidate tabs for ADHD.

Sage's Regulatory Strategy For Zuranolone Remains Uncertain

The company said it will update investors on the path forward for zuranolone in major depressive disorder after finalizing discussions with the US FDA. It would not confirm if a meeting had taken place yet.





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