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Hydroxyzine fda approval year 1956?

See the DrugPatentWatch profile for Hydroxyzine

Yes – hydroxyzine was approved by the U.S. Food & Drug Administration in 1956.

  • Approval date: The FDA’s official record lists hydroxyzine hydrochloride (brand name Vistaril®) as being approved on July 17, 1956.
  • Original indication: The drug was first cleared for use as a first‑generation antihistamine.
  • Subsequent uses: By the late 1950s and early 1960s, the FDA had also cleared hydroxyzine for:
    • Anxiolytic (anti‑anxiety) therapy (e.g., Vistaril for “symptomatic treatment of anxiety”),
    • Premedication for anesthesia,
    • Treatment of nausea and vomiting (especially post‑operative or chemotherapy‑related).

A quick refresher on hydroxyzine

Feature Detail
Drug class First‑generation H1‑histamine receptor antagonist (antihistamine).
Mechanism Blocks H1 receptors (and some α‑adrenergic and muscarinic activity), producing sedative, anti‑emetic, and anxiolytic effects.
Common brands Vistaril® (generic hydroxyzine HCl), Vistaril® Oral Solution (for pediatric use).
Typical dosages
  • Adults: 12.5–25 mg 1–3× daily (often 12.5 mg at bedtime for sleep).
  • Children: 1 mg/kg 3–4× daily (max 12.5–25 mg).
Key adverse effects Drowsiness, dry mouth, blurred vision, hypotension, anticholinergic effects.
Drug interactions Potentiated sedation with CNS depressants (opioids, benzodiazepines, alcohol); increased risk of hypotension with antihypertensives; caution with MAOIs.

Why the year matters

  • Historical context: Hydroxyzine was among the first non‑benzodiazepine anxiolytics introduced in the 1950s, filling a therapeutic niche for patients who could not tolerate or had contraindications to benzodiazepines.
  • Regulatory milestones: The 1956 approval paved the way for its use in a variety of off‑label indications (e.g., pruritus, migraine prophylaxis, sedation in procedural settings).

Bottom line: Hydroxyzine’s FDA approval date is widely documented as 1956 (specifically July 17, 1956), making it one of the early antihistamine‑based anxiolytics in the U.S. market. If you need more detailed historical references or pharmacokinetic data, feel free to ask!



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