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

Pfizer’s Lyrica Is “Approvable” At FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Neurontin follow-on drug pregabalin receives second “approvable” decision in two months. Pfizer is looking to convert Neurontin patients to the successor product in the face of gabapentin generics.

You may also be interested in...



Pfizer's Lyrica: "Approvable" For Three Indications, But Not Generalized Anxiety

The company received a "non-approvable" letter for the treatment of generalized anxiety disorder. Pfizer says it is working with FDA to resolve "open issues on all indications" for the Neurontin follow-on agent.

Pfizer's Lyrica: "Approvable" For Three Indications, But Not Generalized Anxiety

The company received a "non-approvable" letter for the treatment of generalized anxiety disorder. Pfizer says it is working with FDA to resolve "open issues on all indications" for the Neurontin follow-on agent.

Ivax Launches Neurontin Generic As User Fee Date For Pfizer's Pregabalin Nears

Non-AB-rated gabapentin tablets launch "at risk" less than two weeks before the estimated Aug. 30 user fee deadline for Pfizer's follow-on drug Lyrica. Pfizer is seeking a temporary restraining order against Ivax.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS060513

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