METHYLPREDNISOLONE ACETATE · WATSON LABS INC
A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of methylprednisolone acetate injectable suspension is indicated as follows: Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersen...
Details
- Status
- Prescription
- First Approved
- 1957-10-24
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
METHYLPREDNISOLONE ACETATE Approval History
What METHYLPREDNISOLONE ACETATE Treats
10 indicationsMETHYLPREDNISOLONE ACETATE is approved for 10 conditions since its original approval in 1979. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Atopic Dermatitis
- Contact Dermatitis
- Drug Hypersensitivity
- Serum Sickness
- Transfusion Reaction
- Bullous Dermatitis Herpetiformis
- Exfoliative Dermatitis
- Mycosis Fungoides
- Pemphigus
METHYLPREDNISOLONE ACETATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 METHYLPREDNISOLONE ACETATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications METHYLPREDNISOLONE ACETATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to METHYLPREDNISOLONE ACETATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03913702 results posted | UTMB IRB #: 18-0156 | Ph 2 | terminated | Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement |
| NCT03794505 | F-2018-3401-056 | Ph 3 | completed | Quality of Life and Pain With Infiltration or Suprascapular Nerve Block in Glenohumeral Arthirtis |
| NCT02847494 results posted | 2016-6342 | Ph 4 | completed | Corticosteroids for Acute Migraine in the Emergency Department |
| NCT02403856 CALCECHO | RC15_0019 | Ph 4 | completed | Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection |
| NCT01652495 TPESP2011-12 results posted | 2012-000866-40 | Ph 4 | completed | Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
METHYLPREDNISOLONE ACETATE FDA Label Details
Indications & Usage
A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intramuscular use of methylprednisolone acetate injectable suspension is indicated as follows: Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic Diseases: Bullous dermatitis...
Looking for the branded version?
DEPO-MEDROL
Full clinical data, patents, trials, and competitive landscape for methylprednisolone acetate.
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.