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


Wyeth predicts quick response to Tygacil "approvable" letter

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Wyeth anticipates submitting a complete response to FDA's "approvable" letter for a new community-acquired pneumonia indication for its I.V. antibiotic Tygacil (tigecycline) by June 27, the company says after announcing receipt of the letter on May 29. On that timetable, the sNDA would have a user fee goal of Dec. 22. FDA requested additional analyses of the antibiotic "in patients with CAP with illness severe enough to require hospitalization, including those who are at higher risk of mortality," Wyeth says. FDA also asked for benefit/risk information on the potential for liver toxicity; Wyeth maintains that such information was presented to FDA during the review period, noting that "the agency acknowledged in its letter that it had not yet reviewed that information.

You may also be interested in...

Turkish Medtechs Face The Constant Challenge Of Sailing In Stormy Seas

The pandemic has exacerbated the problems of the Turkish medical device industry, which was already struggling for survival and growth in a hostile policy environment. Local blood bag manufacturer Kansuk Laboratory talked to Medtech Insight about the difficulties it faces.

Pipeline Watch: Phase III Readouts For COVID-19, Dry Eye Disease, Uveal Melanoma

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Ireland’s Supply Chain Suffers Due To Brexit And Covid

Medicines for Ireland has released a report focusing on the direct impact of Brexit and COVID-19 on the medicines supply chain. The association has called for long-term plans and solutions instead of temporary fixes for issues related to delays in the import and export of medicines. 





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