BLA 21839, held by Ipsen Inc. Mecasermin Recombinant.
As of Nov 13, 2026, BLA 21839 (Increlex), held by Ipsen Inc, was first approved by FDA on Aug 30, 2005, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 15, 2024 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Aug 30, 2005 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Increlex40MG/4ML (10MG/ML) · injectable;subcutaneous | Mecasermin Recombinant | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 9, 2025 | Supplement 33Labeling · Standard review | Approved | |
| Mar 15, 2024 | Supplement 31Efficacy (new indication or use) · Standard review | Approved | |
| Oct 20, 2023 | Supplement 27Labeling · Standard review | Approved | |
| Dec 3, 2019 | Supplement 24Labeling · Standard review | Approved | |
| Jan 18, 2019 | Supplement 21Labeling · Standard review | Approved | |
| Mar 15, 2016 | Supplement 17Labeling · Standard review | Approved | |
| Jun 3, 2014 | Supplement 16Labeling · Standard review | Approved | |
| Jan 16, 2013 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Sep 13, 2012 | Supplement 10Labeling | Approved | |
| Jun 14, 2012 | Supplement 12Labeling | Approved | |
| Feb 16, 2011 | Supplement 7Labeling · Standard review | Approved | |
| Aug 30, 2005 | Original applicationNew molecular entity · Priority review | Approved |
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
