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.

Menu

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
My View
Tags:
Consumer OTC Drugs

DynaGen's NicErase lobeline smoking cessation product under development.

This article was originally published in The Tan Sheet

  • News
  • The Tan Sheet

Executive Summary

DYNAGEN's NICERASE NON-NICOTINE SMOKING CESSATION PRODUCT DATA are expected to be discussed at an upcoming meeting with FDA, according to the Cambridge, Mass.-based company. DynaGen, which completed Phase III pilot trials for its prescription NicErase smoking cessation sublingual tablet at the end of March, said it hopes to meet with the agency in June to discuss the clinical trial results and determine whether additional studies are needed before filing an NDA. The company intends to pursue OTC status for NicErase following Rx approval.

Table

View full table

Topics

Tags:
Consumer OTC Drugs
Latest Headlines

Priority Review Vouchers: Tropical Disease Candidates Wait Years For FDA Action On Qualifying List

Pink Sheet Podcast: US FDA Biosimilar Strategy, Gene Therapy Accelerated Approvals, FDA v. Partisan Politics

Idorsia’s Novel Hypertension Pill Among Eight New Drugs To Win EMA Nod

AI Used In Drug R&D Likely Exempt From Tough EU AI Rules, Says EFPIA

See All
UsernamePublicRestriction

Register

PS083814

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

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