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


Teva Agilect "approvable" again

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Teva Parkinson's disease treatment Agilect (rasagiline) receives a second "approvable" letter Aug. 4. "There remain a number of issues that Teva believed it had resolved with its submissions, but [where] FDA continues to have concerns," the sponsor states Aug. 5. The firm plans to meet with the agency "promptly" to address the remaining concerns. Teva responded to a July 2004 approvable letter last November, but the review was extended by three months due to a technical error with the NDA...

You may also be interested in...

FDA Turns To Epidemiological Data To Resolve Azilect Melanoma Questions

FDA used an epidemiological approach to resolve concerns regarding a potentially higher risk of melanoma with Teva’s Parkinson’s disease therapy Azilect, review documents show.

QUOTED. 10 April 2020. Shawn Patterson.

3D-printing company Carbon and in vitro diagnostics maker Resolution Medical announced plans to manufacture more than one million 3D-printed nasal swabs per week to test for COVID-19. See what Resolution Medical’s president Shawn Patterson said about it here.

Bleach Mixtures Return To US Regulatory Radar Making COVID-19 Treatment Claims

FDA warning to "Genesis II Church of Health and Healing " wasn't its first to the organization about promoting a chlorine dioxide formulation, "Miracle Mineral Solution," as an unapproved new drug. 'Infowars' host Alex Jones also was warned about bogus COVID-19 claims.





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