Treats onchocerciasis due to Onchocerca volvulus. NDA 210867, held by Mdgh. Moxidectin.
As of Nov 13, 2026, NDA 210867 (Moxidectin), held by Mdgh, was first approved by FDA on Jun 13, 2018, with 3 approved supplements and 0 published complete response letters.
Moxidectin Tablets are indicated for the treatment of onchocerciasis due to Onchocerca volvulus in adult and pediatric patients aged 4 years and older and weighing at least 13 kg. Limitations of Use: Moxidectin Tablets does not kill adult Onchocerca volvulus (O. volvulus) parasites. Follow-up evaluation is advised. The safety and efficacy of repeat administration of Moxidectin Tablets in patients with O. volvulus has not been studied.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2025 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Jun 13, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Moxidectin2MG · tablet;oral | Moxidectin | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2025 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Mar 5, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Jan 18, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Jun 13, 2018 | 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
