Regranex

Treats lower extremity diabetic neuropathic ulcers. BLA 103691, held by Smith And Nephew. Becaplermin.

As of Nov 13, 2026, BLA 103691 (Regranex), held by Smith And Nephew, was first approved by FDA on Dec 16, 1997, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 16, 1997
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Nov 28, 2018	Supplement 5134Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
May 13, 2005	Supplement 5015Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 16, 1997	Original applicationNew molecular entity	Approved	Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Regranex100UG/G · gel; topical	Becaplermin	Rx

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 26, 2019	Supplement 5138Labeling · Standard review	Approved	Letter Label Medication Guide
Nov 28, 2018	Supplement 5134Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Apr 30, 2012	Supplement 5109Labeling · Standard review	Approved	Letter
Mar 11, 2011	Supplement 5095Labeling · Standard review	Approved	Label
Apr 28, 2010	Supplement 5087Labeling · Standard review	Approved	None posted
Apr 9, 2010	Supplement 5086Labeling · Standard review	Approved	None posted
Oct 16, 2008	Supplement 5074Labeling · Standard review	Approved	Label Letter
May 13, 2005	Supplement 5015Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 16, 1997	Original applicationNew molecular entity	Approved	Label Letter

Identifiers

Application: BLA 103691
Drugs@FDA: Overview at FDA
Company: Smith & Nephew

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters