Cefditoren Pivoxil

Sold as Spectracef. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Cefditoren Pivoxil (sold as Spectracef), first approved Aug 29, 2001, with 1 new use approved and 0 published complete response letters.

First approved: Aug 29, 2001
Applications: 1
New uses approved: 1
Complete response letters: 0

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Meiact MS FineA drug with a new additional dosage for the treatment of pneumonia, otitis media, and sinusitis. · Meiji Seika Pharma Co., Ltd. · Jun 22, 2012

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Effectiveness and Safety of Outpatient Treatment of Uncomplicated Acute Diverticulitis Without AntibioticsDiverticulitis, Colonic · Monica Mengual Ballester	Not applicable	Enrolling by invitation	Jul 24, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Aug 29, 2001	SpectracefNDA 21222 · New molecular entity	Vansen Pharma	8	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA