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🏅 FDA Orphan Designation

DROXIA

HYDROXYUREA

Manufacturer: Waylis Therapeutics LLC

Indicated for:
OBSOLETE: Sickle cell disease associated with another hemoglobin anomalyOrphanSickle cell diseaseOrphan
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Black Box Warning (Boxed Warning)

A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.

View full prescribing information on DailyMed (NLM) ↗

FDA-Approved Indications (2)

To reduce the frequency of painful crises and to reduce the need for blood transfusions in adult patients with sickle cell anemia with recurrent moderate to severe painful crises (generally at least 3

Sickle cell diseaseOrphan Designation

1 INDICATIONS AND USAGE DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to sever

Indications & Usage

1 INDICATIONS AND USAGE DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises. DROXIA is an antimetabolite indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises. ( 1 )

💙 Support Programs

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Hydroxyurea
Bristol Myers Squibb
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DROXIA
Bristol Myers Squibb
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Where shown, WAC (Wholesale Acquisition Cost) is an estimate only — your actual cost depends on your insurance plan. Always verify pricing with your pharmacy or insurer.

Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.