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Data updated: May 26, 2026

CELESTONE SOLUSPAN (betamethasone acetate)

Respiratory Approved 1965-03-03

CELESTONE SOLUSPAN is indicated for the treatment of Asthma; Atopic Dermatitis; Contact Dermatitis; Drug Hypersensitivity; Allergic Rhinitis; Serum Sickness; Transfusion Reaction; Dermatitis Herpetiformis; Exfoliative Erythroderma; Mycosis Fungoides.

Source: FDA Label • Merck

How CELESTONE SOLUSPAN Works

Betamethasone is a synthetic glucocorticoid with potent anti-inflammatory and immunosuppressive activity. It diffuses across cell membranes and binds with high affinity to specific cytoplasmic glucocorticoid receptors. This complex translocates to the nucleus, where it binds to glucocorticoid response elements (GREs) on DNA, altering gene expression. This results in the induction of anti-inflammatory proteins (such as lipocortins, which inhibit phospholipase A2) and the inhibition of the synthesis of pro-inflammatory mediators (including prostaglandins, leukotrienes, and various cytokines). The SOLUSPAN formulation provides a dual-effect profile: the highly soluble betamethasone sodium phosphate provides rapid activity, while the slightly soluble betamethasone acetate provides sustained activity through slower absorption.

1
Indication
--
Phase 3 Trials
61
Years on Market

Details

Status
Prescription
First Approved
1965-03-03
Routes
INJECTION
Dosage Forms
INJECTABLE

CELESTONE SOLUSPAN Approval History

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Original
New Indication
New Form
Label Update
31 FDA actions from 1965 to 2024
Jul 2024 SUPPL
Label · Labeling
Jun 2024 SUPPL
Label · Labeling
Sep 2022 SUPPL
Label · Labeling

What CELESTONE SOLUSPAN Treats

10 indications

CELESTONE SOLUSPAN is approved for 10 conditions since its original approval in 1965. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Asthma
  • Atopic Dermatitis
  • Contact Dermatitis
  • Drug Hypersensitivity
  • Allergic Rhinitis
  • Serum Sickness
  • Transfusion Reaction
  • Dermatitis Herpetiformis
Source: FDA Label

CELESTONE SOLUSPAN Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in CELESTONE SOLUSPAN's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CELESTONE SOLUSPAN treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to CELESTONE SOLUSPAN

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CELESTONE SOLUSPAN FDA Label Details

Indications & Usage

FDA Label (PDF)

CELESTONE SOLUSPAN is indicated for the treatment of Asthma; Atopic Dermatitis; Contact Dermatitis; Drug Hypersensitivity; Allergic Rhinitis; Serum Sickness; Transfusion Reaction; Dermatitis Herpetiformis; Exfoliative Erythroderma; Mycosis Fungoides.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.