Prescription medicine
Becaplermin Brand names: Regranex
Becaplermin (Regranex) is a prescription medicine with an FDA approval on record since 1997. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the becaplermin FDA label on DailyMed (effective May 8, 2026, LRM Therapeutics, LLC); the BLA 103691 record on Drugs@FDA; every becaplermin label on DailyMed.
Highlights of the record
FDA label of May 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageREGRANEX is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.
Forms and strengths
- 0.1 mg/g
Gel.
On the market
- Earliest approval on file
- December 16, 1997 Regranex, Smith And Nephew; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1 through July 30, 2026
What is becaplermin used for?
From the label: indications and usageREGRANEX is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control. […]
FDA pharmacologic class: Human Platelet-derived Growth Factor.
Source: FDA drug label (Regranex Gel 0.01%), BLA103691 (Smith And Nephew), as published by LRM Therapeutics, LLC, effective May 8, 2026 (SPL set 377b3021-13d7-96d5-e063-6394a90a8ca3), via openFDA; the full label on DailyMed
What does the patient leaflet for becaplermin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about REGRANEX?REGRANEX may cause serious side effects, including: Risk of cancer. Cancers have happened in areas away from the REGRANEX application site. You and your healthcare provider should carefully consider whether you will use REGRANEX if you have cancer.
From the patient leaflet: How should I store REGRANEX?Store REGRANEX in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze REGRANEX. Do not use REGRANEX after the expiration date on the bottom (sealed end) of the tube. Throw away your REGRANEX that is out of date or no longer needed for your treatment. Keep REGRANEX and all medicines out of the reach of children.
Source: FDA drug label (Regranex Gel 0.01%), BLA103691 (Smith And Nephew), as published by LRM Therapeutics, LLC, effective May 8, 2026 (SPL set 377b3021-13d7-96d5-e063-6394a90a8ca3), via openFDA; the full label on DailyMed
Is there a generic for becaplermin (Regranex)?
No generic becaplermin is approved (Drugs@FDA, October 8, 2026).
- 1997 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for becaplermin?
The FDA Adverse Event Reporting System holds 1 report that list becaplermin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Becaplermin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other