NDAORALFOR SUSPENSION
Approved
Jan 1971
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
3/8 — Basic
KEFLEX (cephalexin) by Pragma Bio is [see microbiology ( )] . First approved in 1971.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KEFLEX (cephalexin) is an oral first-generation cephalosporin antibiotic approved in 1971 for treating bacterial infections. It inhibits bacterial cell wall synthesis by binding penicillin-binding proteins. The suspension formulation enables pediatric and patients unable to swallow capsules.
LOE Approaching
As LOE approaches, the brand team is likely focused on lifecycle management and volume maintenance rather than growth initiatives, with smaller commercial footprint.
Mechanism of Action
[see Microbiology ( )] .
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
Oral Amoxicillin and Cephalexin PK/PD in Neonates
Started Jul 2021
72 enrolled
Neonatal Infection
Cefadroxil and Cephalexin Drug Levels and Dosing in Pediatric Musculoskeletal Infections
Started May 2019
17 enrolled
OsteomyelitisSeptic ArthritisPyomyositis
A Study of Cephalexin Liquid in Healthy Participants
Started Jul 2015
28 enrolled
Healthy
A Study of Cephalexin Liquid for Pediatrics in Healthy Adults Participants
Started May 2014
28 enrolled
Healthy Volunteers
A Study of Cephalexin Suspension in Healthy Participants
Started May 2014
28 enrolled
Healthy Volunteers
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.