TheraRadar
Data updated: May 26, 2026

CEFOTAN (cefotetan disodium)

Trial Activity: Stable 1 active trials
Infectious Disease Approved 1985-12-27

CEFOTAN is indicated for the treatment of Urinary Tract Infection; Lower Respiratory Tract Infection; Skin and Skin Structure Infection; Gynecologic Infection.

Source: FDA Label • TELIGENT
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

Development Insights

Oregon Health and Science University conducting 1 trials (33%)
4 indications explored (Focused)
→ e coli infection (1 trials)
→ esbl producing e.coli (1 trials)
→ cholecystitis (1 trials)
3
Indications
--
Phase 3 Trials
40
Years on Market

Details

Status
Discontinued
First Approved
1985-12-27
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

TELIGENT PAI HOLDINGS PHARM
Active Ingredient: CEFOTETAN DISODIUM

CEFOTAN Approval History

1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
62 FDA actions from 1985 to 2017
Mar 2017 SUPPL
Label · Labeling
FDA Letter Label
Dec 2015 SUPPL
Mfg · Manufacturing (CMC)
Jun 2004 SUPPL
Label · Labeling
FDA Letter Label

What CEFOTAN Treats

4 indications

CEFOTAN is approved for 4 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Urinary Tract Infection
  • Lower Respiratory Tract Infection
  • Skin and Skin Structure Infection
  • Gynecologic Infection
Source: FDA Label

CEFOTAN Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

DALBAVANCIN HYDROCHLORIDE
Fresenius Kabi
2025 1 indic.
CONTEPO
MEITHEAL
2025 2 indic.
Unlock 8 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CEFOTAN

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AMOXICILLIN PEDIATRIC
AMOXICILLIN
3 shared
Teva
Shared indications:
Lower Respiratory Tract InfectionSkin and Skin Structure InfectionUrinary Tract Infection
AUGMENTIN '125'
AMOXICILLIN
3 shared
US ANTIBIOTICS
Shared indications:
Lower Respiratory Tract InfectionSkin and Skin Structure InfectionUrinary Tract Infection
AUGMENTIN '250'
AMOXICILLIN
3 shared
US ANTIBIOTICS
Shared indications:
Lower Respiratory Tract InfectionSkin and Skin Structure InfectionUrinary Tract Infection
View all 20 similar drugs Pro
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CEFOTAN FDA Label Details

Indications & Usage

FDA Label (PDF)

CEFOTAN is indicated for the treatment of Urinary Tract Infection; Lower Respiratory Tract Infection; Skin and Skin Structure Infection; Gynecologic Infection.

Track CEFOTAN with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: ANDA063293 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment