CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE (clindamycin phosphate) · Baxter
Clindamycin phosphate is a topical medication that treats acne vulgaris. It is used for patients with skin breakouts, though physicians must carefully consider its use due to the risk of severe side effects like bloody diarrhea and colitis. This medication helps manage acne when a healthcare provider determines it is the most suitable option among available therapies.
How CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE Works
The specific way clindamycin phosphate works to improve acne is currently unknown. While the medication is used to manage this condition, the exact biological mechanism of action has not been established.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-04-20
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE Approval History
What CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE Treats
1 indicationsCLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE Boxed Warning
CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) and COLITIS Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin Phosphate in Sodium Chloride Injection and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Because Clindamycin Phosphate in Sodium Chloride Injection therapy has been associat...
WARNING: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) and COLITIS Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin Phosphate in Sodium Chloride Injection and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Because Clindamycin Phosphate in Sodium Chloride Injection therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate [ see Indications and Usage ( 1 ) ] . It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated [ see Warnings and Precautions ( 5.1 ) ]. WARNING: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) and COLITIS See full prescribing information for complete boxed warning. Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin Phosphate in Sodium Chloride Injection and may range in severity from mild diarr
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04469075 | 19-342 | Ph 2 | active not recruiting | Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields |
| NCT04321070 | CLPL 1907 | Ph 1 | completed | Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris |
| NCT00616330 | CBC-302-602-622467 | Ph 3 | completed | Vaginal Infection Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Clindamycin Phosphate in Sodium Chloride Injection contains clindamycin, a lincosamide antibacterial indicated for the treatment of the following in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: • Serious infections caused by susceptible anaerobic bacteria • Infections Due to Susceptible Isolates of Streptococci, Pneumococci and Staphylococci. • Lower Respiratory Tract Infections. • Skin and Skin Structure Infections. • Gynecological Infections. • Intra-abdominal Infections. • Septicemia. • Bone and Joint Infections. Limitation of use Since cli...
WARNING: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD) and COLITIS Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Clindamycin Phosphate in Sodium Chloride Injection and may range in severity from mild diarrhea to fa...
Track CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
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