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

Amneal Loses Bid For 180-Day Generic Exclusivity On Namenda XR

Executive Summary

US FDA's demand for commercial-scale data for memantine extended-release during ANDA review did not amount to change in 'requirements for approval,' judge rules, upholding agency determination that Amneal forfeited marketing exclusivity for failure to obtained tentative approval within 30 months.

You may also be interested in...



Teva Sues US FDA To Obtain 180-Day Exclusivity For Its Generic Restasis

Complaint challenges agency's revised definition of "first applicant," which does not require notice of Paragraph IV certification to obtain exclusivity.

Teva Sues US FDA To Obtain 180-Day Exclusivity For Its Generic Restasis

Complaint challenges agency's revised definition of "first applicant," which does not require notice of Paragraph IV certification to obtain exclusivity.

Rescinding A Refuse-To-File: A Precedent Of Sorts

US FDA’s decision to rescind refuse-to-file letter for Alkermes’ high-profile depression drug is extremely unusual – but not literally unprecedented. One prior example of rescinding an RTF involves an ANDA.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS122417

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