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Moxidectin FDA Approval History

Last updated by Judith Stewart, BPharm on July 27, 2020.

FDA Approved: Yes (First approved June 13, 2018)
Generic name: moxidectin
Dosage form: Tablets
Company: Medicines Development for Global Health
Treatment for: Onchocerciasis, River Blindness

Moxidectin is a macrocyclic lactone anthelmintic medicine indicated for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older.

Dosage and Administration

The dosage for moxidectin in patients aged 12 years and over with Onchocerca volvulusis infection is 8 mg (four 2 mg tablets) taken as a single oral dose, with or without food.

Adverse Reactions

The most common adverse reactions (incidence > 10%) include eosinophilia, pruritus, musculoskeletal pain, headache, lymphopenia, tachycardia, rash, abdominal pain, hypotension, pyrexia, leukocytosis, influenza-like illness, neutropenia, cough, lymph node pain, dizziness, diarrhea, hyponatremia and peripheral swelling.

Development timeline for moxidectin

Jun 13, 2018Approval FDA Approves Moxidectin for the Treatment of River Blindness

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.