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

Bayer Avelox Skin Infection Indication "Approvable"; Needs More Safety Data

Executive Summary

Bayer's Avelox (moxifloxacin) is "approvable" for the treatment of uncomplicated skin and skin structure infections, FDA said in a Dec. 10 letter granting the antibiotic approval for three other indications.

You may also be interested in...



Glaxo Withdraws Raxar Following Seven Fatal Cardiovascular AEs

Glaxo Wellcome is withdrawing the quinolone antibiotic Raxar (grepafloxacin) from the worldwide markets after receiving a total of seven reports of cardiovascular event-related fatalities associated with use of the drug.

Bayer Avelox Cardiac Safety Studies Recommended By FDA Committee

Cardiac QT prolongation associated with Bayer's fluoroquinolone Avelox (moxifloxacin) should be evaluated in high risk patients, FDA's Anti-Infective Drugs Advisory Committee concluded Oct. 21.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

Latest Headlines
See All
UsernamePublicRestriction

Register

PS035318

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