E-DRUG: Withdrawal of gatifloxacine in US
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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Register that TEQUIN (Gatifloxacin) was withdrawn from sale for reasons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.
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(gatifloxacin) Tablets, Injection, and Oral Suspension, were withdrawn from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