Lampit FDA Approval History
FDA Approved: Yes (First approved August 6, 2020)
Brand name: Lampit
Generic name: nifurtimox
Dosage form: Tablets
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Chagas Disease
Lampit (nifurtimox) is a nitrofuran antiprotozoal used for the treatment of Chagas disease (American Trypanosomiasis) in pediatric patients.
- Lampit is indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi. This indication is approved under accelerated approval based on the number of treated patients who became immunoglobulin G (IgG) antibody negative or who showed an at least 20% decrease in optical density on two different IgG antibody tests against antigens of T. cruzi. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- Lampit tablets are administered orally, three times daily with food for 60 days. For patients who cannot swallow tablets, Lampit can be dispersed in water and administered as a slurry.
- Common adverse reactions include vomiting, abdominal pain, headache, decreased appetite, nausea, pyrexia, and rash.
Development Timeline for Lampit
|Aug 7, 2020||FDA Approves Lampit (nifurtimox) for the Treatment of Chagas Disease in Children|
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