NDA 21717, held by Crescita Therap. Lidocaine; Tetracaine.
As of Nov 15, 2026, NDA 21717 (Pliaglis), held by Crescita Therap, was first approved by FDA on Jun 29, 2006, with 6 approved supplements and 0 published complete response letters.
PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 29, 2006 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pliaglis7%;7% · cream;topical | Lidocaine; Tetracaine | RxReference drug |
| Dec 11, 2018 | Supplement 10Labeling · Standard review | Approved | |
| Nov 2, 2018 | Supplement 11Labeling · Standard review | Approved | |
| Nov 21, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Mar 9, 2015 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Nov 7, 2013 | Supplement 5Labeling · Standard review | Approved | |
| Jun 28, 2007 | Supplement 2Labeling · Standard review | Approved | |
| Jun 29, 2006 | Original applicationNew combination · Standard 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
