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.

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

Nuvo/Mallinckrodt’s Pennsaid Setback Starts Clock On Generic Launch

This article was originally published in The Pink Sheet Daily

Executive Summary

With Nuvo’s new Pennsaid 2% formulation hung up at FDA, Apotex may be able to launch its generic of the old 1.5% formulation of the topical diclofenac product on April 1, 2014, under a settlement announced in January.

You may also be interested in...



Nuvo/Galderma Face More Manufacturing Woes Over Topical Anesthetic

Galderma pulled Pliaglis from the market in 2008 over manufacturing issues, which the specialty pharma thought were resolved when it submitted an sNDA last fall. Regulators, however, still have questions surrounding the daub on, peel off product’s manufacture, which has now been transferred from a third-party to Galderma.

Covidien Pure-Play: Pharma Spin-Off Now Officially In The Works

Covidien says it has been working for several years towards separating out its pharma business from its larger and more profitable devices/supplies division.

Nuvo's Pennsaid “Approvable” For Osteoarthritis

Company plans to meet with FDA in early 2007 to discuss the topical non-steroidal anti-inflammatory treatment.

Topics

Related Companies

Related Deals

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075480

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