Based on a Federal Register (FR) notice issued in December 2023 (here), the FDA has determined that ciprofloxacin 100 mg tablets taken in a three-day regimen to treat uncomplicated urinary tract infections are ineffective based on resistance developed over time to E. coli, the primary causative agent for uncomplicated UTIs (see previous post here). Since that time, all of the sponsors of NDA and ANDA products that were previously approved for 100 mg ciprofloxacin tableted product have withdrawn their applications at the FDA.
In the prepublication page of the FR today (here), the FDA announced its final determination that ciprofloxacin 100 mg tablets are no longer safe or effective for their intended use in treating uncomplicated UTIs. This means that the FDA will no longer accept NDAs or ANDAs for the previously approved 100 mg tableted product. The FR notice explains the history of the approval and the events that led the Agency to this final decision. In addition, in the December 2023 FR notice (cited above), the FDA noted that “significant adverse reactions associated with the use of fluoroquinolones, including ciprofloxacin HCl, have been identified. Given that the safe and effective use of ciprofloxacin hydrochloride tablets, 100 mg twice daily for 3 days for the treatment of acute uncomplicated cystitis is not supported by its current STIC [the current ciprofloxacin Susceptibility Test Interpretive Criteria], and considering the risks of serious adverse reactions along with the increased resistance of E. coli to ciprofloxacin, FDA believes that the potential problems associated with ciprofloxacin hydrochloride tablets, 100 mg are sufficiently serious that the product should be removed from the market under § 314.150(d) (21 CFR 314.150(d)).” The FR notice issued today finalizes the FDA’s thinking, concluding that the drug product is no longer safe and effective. Higher strengths of ciprofloxacin in various dosage forms are not affected by this notice.
