Scrip 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

Kyorin Pharmaceutical and Dainippon Sumitomo Halt Gatiflo Sales

This article was originally published in PharmAsia News

Executive Summary

Tokyo based Kyorin Pharmaceutical and Dainippon Sumitomo voluntarily stopped selling oral antibioticGatiflo (gatifloxacin) Sept. 30. U.S. FDA removed gatifloxacin from its approved drug list due to serious side effects such as abnormal blood glucose levels. Manufactured by Kyorin and marketed by Dainippon Sumitomo, gatifloxacin is an oral antibiotic to treat pneumonia and other infections. Kyorin estimates the move will not negatively affect patients as there are many alternatives from other companies. The drug has been administrated to 14.7 million patients in Japan and the two companies reported ¥3.5 billion in Gatiflo sales last year. (Click here for more - Japanese language)

You may also be interested in...



FDA Says GMP Lapses In Facilities And Production Areas More Common For Cell And Gene Therapies

US FDA investigators are more likely to cite cell and gene therapy manufacturers for facilities and production deficiencies, agency says, while industry reports difficulties complying with drug GMP requirements that are not always applicable to cell and gene therapies.

Anti-BCMA Therapies Aim To Raise The Bar In Myeloma

GSK’s antibody-drug conjugate may reach the market first, but CAR-T therapies from Bristol/bluebird and Janssen/Legend are close behind, and all three big pharmas have programs in earlier-stage disease.

The Quality Lowdown: US FDA Finding New Crop Of Data Integrity Problems

Manufacturers warned to keep better electronic records and not falsify data in recent warning letters, ICH adds three residual solvent limits for pharmaceuticals, and the Polish authority hits firm for GMP noncompliance.

UsernamePublicRestriction

Register

LL1132600

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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