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 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KEFLEX (cephalexin) is an oral first-generation cephalosporin antibiotic approved in 1971 that treats bacterial infections by inhibiting bacterial cell wall synthesis. It is available as a suspension formulation for oral administration. The drug is indicated for a broad spectrum of gram-positive and some gram-negative bacterial infections.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30% intensity), the brand team is likely focused on cost management and maintaining market share against generics rather than expansion.
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.