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

UsernamePublicRestriction
UsernamePublicRestriction

EMA Acts On Patient Concerns Over Fluoroquinolone Antibiotics

Executive Summary

Three months after hearing testimonies of patients who suffered severe side-effects from the use of quinolones and fluoroquinolones, the European Medicines Agency has recommended that some of these medicines should be removed from the market and the labeling of others should be changed to restrict their use.

You may also be interested in...



Nabriva Faces Skepticism After Years Of Preparing For Novel Antibiotic Xenleta's Launch

Lefamulin was approved in the US to treat community-acquired bacterial pneumonia, providing a needed IV and oral drug initially in the hospital setting, but new antibiotics have been a tough sell.

42 New Substances Among 84 EU Approval Recommendations In 2018

The EMA’s CHMP recommended EU marketing authorization for a total of 84 new drugs in 2018, containing a total of 42 new active substances. They included the EU’s first two CAR-T cell therapies, Kymriah and Yescarta, which were also among the 21 orphan medicines to gain a positive opinion from the committee.

Two Orphans And An Avastin Biosimilar Among EU Approval Recommendations

Seven new drug applications got the thumbs up this week from the EMA's drug evaluation committee, the CHMP.  Their EU approval should now be a formality. Two new Shionogi treatments are set for approval, as are two orphan products – one from Medac, the other from AOP Orphan Pharmaceuticals. Pfizer got the OK for one biosimilar but has withdrawn an application for another.

Related Content

Topics

UsernamePublicRestriction

Register

LL1134044

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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