# \[e-drug\] Withdrawal of gatifloxacine in US **URL:** https://talk.edrugplus.org/t/e-drug-withdrawal-of-gatifloxacine-in-us/30544 **Category:** e-drug **Created:** [September 20, 2008, 12:43am UTC](https://talk.edrugplus.org/t/e-drug-withdrawal-of-gatifloxacine-in-us/30544 "2008-09-20T00:43:26Z") **Posts on this page:** 1 **Page:** 1
### Author: ![niyada.k](https://avatars.discourse-cdn.com/v4/letter/n/898d66/32.png) [@niyada.k](https://talk.edrugplus.org/u/niyada.k) #### Post date: [September 20, 2008, 12:43am UTC](https://talk.edrugplus.org/t/e-drug-withdrawal-of-gatifloxacine-in-us/30544/1 "2008-09-20T00:43:26Z")
E-DRUG: Withdrawal of gatifloxacine in US ----------------------------------------------------------------------- Dear E-druggers, Please find below recent information from the US published in the Federal Register that TEQUIN (Gatifloxacin) was withdrawn from sale for reasons of safety or effectiveness. [http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-20938.pdf](http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-20938.pdf). Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Notices 52357 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2006-P-0081 (formerly Docket No. 2006P-0178) and FDA-2005-P-0369 (formerly Docket No. 2005P-0023)] SUMMARY: The Food and Drug Administration (FDA) has determined that TEQUIN (gatifloxacin) Tablets, Injection, and Oral Suspension, were withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not accept or approve abbreviated new drug applications (ANDAs) for gatifloxacin oral tablets, injection, or oral suspension that refer to any previously approved dosage forms and strengths of TEQUIN (gatifloxacin). FOR FURTHER INFORMATION CONTACT: Elena Cohen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6228, Silver Spring, MD 20993-0002, 301-796-3602 -- Niyada Kiatying-Angsulee, Ph.D. Chair, Social Pharmacy Research Unit (SPR) Faculty of Pharmaceutical Sciences Chulalongkorn University Phayathai Rd., Bangkok 10330, Thailand T/F. +662-2188443 email: niyada.k@chula.ac.th