Quick answers
- What is Becaplermin gel 0.01% used for?
- The FDA-approved label (Regranex Gel 0.01%, LRM Therapeutics, LLC, May 8, 2026) says: “REGRANEX 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. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Becaplermin gel 0.01% have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Becaplermin gel 0.01%?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Becaplermin gel 0.01% been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Becaplermin gel 0.01%?
- 1 company lists prescription products of Becaplermin gel 0.01% in the FDA NDC Directory, including LRM Therapeutics, LLC.
What Becaplermin gel 0.01% is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
REGRANEX 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. Limitations of Use …
— FDA label: Regranex Gel 0.01%, LRM Therapeutics, LLC, effective May 8, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Gel |
|---|---|
| Route | Topical |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Regranex Gel 0.01% |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- LRM Therapeutics, LLC1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA103691 REGRANEX | Smith and Nephew | December 16, 1997 | 8, latest August 26, 2019 2019: Labeling · 2018: Efficacy · 2012: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 213197, 308579 |
|---|---|
| SPL set ID of the quoted label | 377b3021-13d7-96d5-e063-6394a90a8ca3 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA103691 |
| Active ingredients (FDA) | BECAPLERMIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Regranex Gel 0.01%, LRM Therapeutics, LLC, effective May 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →