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


Wyeth’s Tygacil “Approvable” For CAP, Pushing Back FDA Action Until December

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA seeks more analysis of data on patients with severe illness; Wyeth will submit a "complete response" by June 27.

You may also be interested in...

Wyeth’s Viviant “Approvable” For Osteoporosis

Analysis sought for treatment indication is similar to what FDA requested for prevention setting.

Advanced Life Sciences’ Cethromycin For CAP Cleared For FDA Submission

Firm plans third quarter NDA for mild-to-moderate community-acquired pneumonia indication.

Wyeth’s Tygacil sNDA For Community-Acquired Pneumonia Accepted By FDA

Company tells “The Pink Sheet” DAILY that tigecycline would address needs of patients resistant to other antibiotics, such as J&J’s Levaquin.


Latest News
See All



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