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- Home | XROMI (hydroxyurea) Oral solution
All patients using XROMI should be followed up on a long-term basis with regular blood counts to detect development of leukemia Skin cancer has also been reported in patients receiving long-term hydroxyurea
- Xromi (hydroxyurea) FDA Approval History - Drugs. com
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
- Generic Xromi Availability - Drugs. com
There is currently no therapeutically equivalent version of Xromi available in the United States Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Xromi These medications may be counterfeit and potentially unsafe
- Review - accessdata. fda. gov
Therefore, XROMI (NDA 216593) may be blocked from marketing approval for pediatric patients 2 years of age and older unless XROMI is found to be clinically superior, as defined in the Orphan
- Xromi (hydroxyurea) – New drug approval - OptumRx
— Refer to the Xromi drug label for complete dosing and administration recommendations Rare Disease Therapeutics’ launch plans for Xromi are pending Xromi will be available as a 100 mg mL oral solution
- Xromi (hydroxyurea) – New drug approval - OptumRx
April 4, 2024 - The FDA approved Rare Disease Therapeutics’ Xromi (hydroxyurea), 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
- Xromi (hydroxyurea)
Please refer to your new drug application (NDA) dated and received September 21, 2022, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act
- These highlights do not include all the information needed to use XROMI . . .
XROMI is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older with sickle cell anemia with recurrent moderate to severe painful crises
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