Xromi FDA Approval History
Last updated by Judith Stewart, BPharm on April 30, 2024.
FDA Approved: Yes (First approved April 4, 2024)
Brand name: Xromi
Generic name: hydroxyurea
Dosage form: Oral Solution
Company: Nova Laboratories, Ltd.
Treatment for: Sickle Cell Anemia
Xromi (hydroxyurea) is an antimetabolite indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age to less than 2 years with sickle cell anemia with recurrent moderate to severe painful crises.
- Sickle cell anemia is caused by an abnormal version of hemoglobin (called hemoglobin S) which leads to the formation of sickle-shaped red blood cells. The sickle-shaped blood cells can clump and form blockages in the narrow blood vessels, leading to painful episodes called sickle cell crises.
- Xromi contains hydroxyurea, which is thought to work to reduce the frequency of painful sickle cell crises by promoting the release of cells containing fetal hemoglobin from the bone marrow, which then makes the red blood cells less likely to become sickle-shaped. Hydroxyurea has been used to reduce the frequency of painful crises in adults with sickle cell anemia since the 1980s, and it was formally approved by the FDA for use in adults in 1998, and children in 2017.
- Xromi solution is administered orally once daily.
- Warnings and precautions associated with Xromi include hemolytic anemia, fetal harm, and vasculitic toxicities.
- Common adverse reactions (incidence > 33%) include neutropenia and thrombocytopenia.
Development timeline for Xromi
| Date | Article |
|---|---|
| Apr 4, 2024 | Approval FDA Approves Xromi (hydroxyurea) Oral Solution for Use in Pediatric Patients with Sickle Cell Anemia |
Further information
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