NDA 22221, held by Thea Pharma. Lidocaine Hydrochloride.
As of Nov 14, 2026, NDA 22221 (Akten), held by Thea Pharma, was first approved by FDA on Oct 7, 2008, with 4 approved supplements and 0 published complete response letters.
1- INDICATIONS AND USAGE AKTEN is indicated for ocular surface anesthesia during ophthalmologic procedures in adults and pediatric patients. AKTEN is an amide local anesthetic
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 7, 2008 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Akten3.5% · gel;ophthalmic | Lidocaine Hydrochloride | RxReference drug |
| Nov 21, 2025 | Supplement 11Labeling · Standard review | Approved | |
| Feb 28, 2022 | Supplement 8Labeling · Standard review | Approved | |
| Mar 11, 2014 | Supplement 5Labeling · Standard review | Approved | |
| Dec 7, 2012 | Supplement 2Manufacturing · Standard review | Approved | |
| Oct 7, 2008 | Original applicationNew formulation or manufacturer · 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
