NDA 21756, held by Bausch And Lomb Inc. Pegaptanib Sodium.
As of Nov 15, 2026, NDA 21756 (Macugen), held by Bausch And Lomb Inc, was first approved by FDA on Sep 17, 2004, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 2004 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| MacugenEQ 0.3MG ACID/0.09ML · injectable;intravitreal | Pegaptanib Sodium | DiscontinuedReference drug |
| Jan 26, 2017 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Oct 12, 2011 | Supplement 18Labeling | Approved | |
| Apr 8, 2008 | Supplement 12Manufacturing | Approved | None posted |
| Mar 8, 2006 | Supplement 6Labeling · Standard review | Approved | |
| Mar 8, 2006 | Supplement 7Labeling · Standard review | Approved | |
| Nov 17, 2005 | Supplement 4Labeling · Standard review | Approved | |
| Nov 17, 2005 | Supplement 5Manufacturing · Priority review | Approved | |
| Sep 17, 2004 | 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
