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# Noroxin Not Withdrawn Due to Safety/Effectiveness: FDA
- URL: https://www.fdaweb.com/noroxin-not-withdrawn-due-to-safety-effectiveness-fda/
- Published: 2017-12-12T12:00:00.000Z
- Updated: 2026-09-14T23:07:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140318

*Federal Register* notice: FDA has determined that Merck’s Noroxin (norfloxacin) tablets, 400 mg, was not withdrawn due to safety or effectiveness concerns. The determination will allow FDA to approve ANDAs citing the reference product if all other legal and regulatory requirements are met. Noroxin is indicated for treating adults with the following infections caused by susceptible strains of certain designated microorganisms: Uncomplicated urinary tract infections (including cystitis), uncomplicated urethral and cervical gonorrhea, and prostatitis. In April, Jubilant Generics Ltd. submitted a citizen petition requesting that the agency make the determination. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-12-12/pdf/2017-26693.pdf?ref=fdaweb.com).