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Altabax (RETAPAMULIN)
Altabax (Retapamulin) is a pleuromutilin antibacterial small molecule developed by Glaxo Group Ltd and currently owned by Almirall. It was FDA-approved in 2007 for the treatment of impetigo and superficial bacterial skin infections. Altabax works by inhibiting protein synthesis in bacteria, ultimately leading to bacterial cell death. It is a patented medication with no generic manufacturers available. Key safety considerations include potential skin irritation and allergic reactions.
At a glance
| Generic name | RETAPAMULIN |
|---|---|
| Sponsor | Almirall |
| Drug class | Pleuromutilin Antibacterial |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2007 |
Approved indications
- Impetigo
- Superficial bacterial infection of skin
Common side effects
- Headache
- Application site irritation
- Diarrhea
- Nausea
- Nasopharyngitis
- Application site pruritus
- Pruritus
- Eczema
- Pyrexia
Serious adverse events
- Creatinine phosphokinase increased
Key clinical trials
- Treatment of Staphylococcus Aureus Colonization in Hand Eczema (NA)
- Retapamulin as a Decolonizing Agent for MRSA (PHASE3)
- Efficacy Study of Altabax to Clear Methicillin-resistant Staphylococcus Aureus (MRSA) Nasal Colonization (PHASE4)
- Retapamulin for Reducing MRSA Nasal Carriage (PHASE4)
- Retapamulin Microdialysis Feasibility Study (PHASE1)
- Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA (PHASE3)
- Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (PHASE2)
- Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Altabax CI brief — competitive landscape report
- Altabax updates RSS · CI watch RSS
- Almirall portfolio CI