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Details for Generic Name: prednisolone acetate

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Prednisolone acetate is the generic ingredient in eighteen branded drugs marketed by Schering, Akorn, Bel Mar, Cent Pharms, Watson Labs, Pfizer, Alcon, Allergan, Taro, Pharmafair, Novartis, and Bausch And Lomb, and is included in twenty-seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are seventy-nine drug master file entries for prednisolone acetate. Twelve suppliers are listed for this compound.

Summary for Generic Name: prednisolone acetate

Drug Master File Entries: see list79
Suppliers: see list12
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Ophthalmic Agents

Pharmacology for Ingredient: prednisolone acetate

Clinical Trials for: prednisolone acetate

A Comparison of Three Different Formulations of Prednisolone Acetate 1%
Status: Completed Condition: Glaucoma; Cataract

A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
Status: Completed Condition: Eye Infections; Postoperative Complications

Prednisolone Priming Study in Patients With Chronic Hepatitis B
Status: Recruiting Condition: Chronic Hepatitis B

Biomarkers of Prednisolone Treatment (P05888)
Status: Completed Condition: Insulin Resistance; Hyperglycemia; Glucose Intolerance

Preoperative Methylprednisolone in Endovascular Aortic Repair
Status: Completed Condition: Abdominal Aortic Aneurysms

The Efficacy of Three Months-prednisolone Therapy for Chronic Eosinophilic Pneumonia
Status: Completed Condition: Eosinophilic Pneumonia; Chronic Disease

Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone
Status: Terminated Condition: Multiple Sclerosis

Methylprednisolone N Acetylcysteine in Hepatic Resections
Status: Terminated Condition: Ischemic Reperfusion Injury; Insufficiency; Hepatic, Postoperative; Liver Tumour

Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis
Status: Completed Condition: Progressive Multiple Sclerosis

Prednisolone Pharmacokinetics in Severe Asthma
Status: Recruiting Condition: Asthma

Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.
Status: Completed Condition: Cataracts; Corneal Edema; Retinal Structural Change, Deposit and Degeneration; Visual Acuity Reduced Transiently

Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)
Status: Suspended Condition: Acute Exacerbation of Remitting Relapsing Multiple Sclerosis; Clinically Isolated Syndrome

Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in Cortisosensitive Dermatosis
Status: Not yet recruiting Condition: Dermatitis, Atopic; Dermatitis, Contact; Dermatitis, Seborrheic; Psoriasis

Oral Prednisolone Dosing in Children Hospitalized With Asthma
Status: Completed Condition: Asthma

Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms
Status: Not yet recruiting Condition: Infantile Spasms

Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
Status: Terminated Condition: Refractory Mycoplasma Pneumoniae Pneumonia

Study of SB681323 and Prednisolone on Biomarkers in COPD (Chronic Obstructive Pulmonary Disease) Patients
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive

Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus
Status: Recruiting Condition: Stomatitis; Oral Mucositis; Neoplasm of the Breast; Malignant Tumor of Breast

Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis
Status: Completed Condition: Rheumatoid Arthritis

A Randomized Study of IVIG vs. IVIG With High Dose Methylprednisolone in Childhood ITP.
Status: Recruiting Condition: Immune Thrombocytopenic Purpura

A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

Efficacy of Moxifloxacin/Prednisolone in Prevention of Post Surgery Inflammation
Status: Not yet recruiting Condition: Eye Infection/Inflammation Other

Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary Syndrome
Status: Completed Condition: Hantavirus Infections

Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation
Status: Completed Condition: Infection and Inflammation After Refractive Surgery (Lasik).

Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis
Status: Enrolling by invitation Condition: Rheumatoid Arthritis

Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery
Status: Completed Condition: Cataracts; Inflammation

Effect of Methylprednisolone on Quadriceps Muscle Function in Patients Undergoing Total Knee-arthroplasty
Status: Not yet recruiting Condition: Osteoarthrosis

Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery
Status: Completed Condition: Pain,; Edema,; Trismus

Methylprednisolone Addition in IVF Treatment of Infertile Couples
Status: Recruiting Condition: In Vitro Fertilization

Effects of Methylprednisolone After Total Knee Arthroplasty
Status: Completed Condition: Postoperative Pain; Postoperative Nausea and Vomiting; Sleeping Quality; Fatigue; Inflammatory Response

Effects of Methylprednisolone After Total Hip Arthroplasty
Status: Completed Condition: LOS; Postoperative Pain; Postoperative Nausea and Vomiting; Sleeping Quality; Fatigue; Inflammatory Response

A Study to Compare Ocular Safety and Tolerability of Eye Drops Containing Prednisolone Acetate in Patients With Intraocular Inflammation After Cataract Surgery
Status: Completed Condition: Cataract Surgery

The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy
Status: Completed Condition: Hysterectomy; Methylprednisolone; Postoperative Pain

Dexamethasone Versus Depo Medrol in Lumbar Epidurals
Status: Terminated Condition: Lumbar Spine Disc Herniation; Lumbar Radiculitis; Lumbar Back Pain

Evaluation of Efficacy of Coadministration of FOV1101-00 and Prednisolone Acetate in Patients With Mild Ongoing Ocular Allergic Inflammation
Status: Completed Condition: Allergic Conjunctivitis

Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS in Children
Status: Not yet recruiting Condition: Acute Lung Injury; Acute Respiratory Distress Syndrome

Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis
Status: Recruiting Condition: Acute Alcoholic Hepatitis

Arthralgia of the Temporomandibular Joint. Pain Relief Following One Intra-articular Injection of Methylprednisolone
Status: Recruiting Condition: Arthralgia; TMJ

Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease
Status: Recruiting Condition: Minimal Change Disease

A Trial of Adjunctive Prednisolone and Mycobacterium w Immunotherapy in Tuberculous Pericarditis
Status: Completed Condition: Tuberculous Pericarditis

Pharmacokinetics of Prednisone, Prednisolone, Methylprednisolone in Children
Status: Recruiting Condition: Children Receiving Prednisone or Prednisolone or Methylprednisolone

Systemic Methylprednisolone in Chronic Rhinosinusitis
Status: Completed Condition: Chronic Rhinosinusitis; Children

Treatment of Renal Sarcoidosis by Methylprednisolone Bolus
Status: Recruiting Condition: Renal Sarcoidosis

Clinical Study to Assess the Effects of SRT2104 and Prednisolone on Biomarkers in Blood in Healthy Volunteers
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive; Healthy Volunteer

Ciclosporin in the Management of New Type 1 Reactions in Leprosy
Status: Not yet recruiting Condition: Leprosy

Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis
Status: Recruiting Condition: Subacromial Bursitis; Shoulder Pain

Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
Status: Recruiting Condition: Cataract

Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee
Status: Completed Condition: Osteoarthritis of the Knee

Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL)
Status: Active, not recruiting Condition: Ankylosing Spondylitis

Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge Model
Status: Completed Condition: Allergic Conjunctivitis

CRx-102 Osteoarthritis Multicenter Evaluation Trial
Status: Terminated Condition: Knee Osteoarthritis

High-dose Methylprednisolone and Rituximab in High Risk B-CLL
Status: Completed Condition: Chronic B-Lymphocytic Leukemia

A Proof of Concept Study to Determine the Local Delivery and Efficacy of Nanocort
Status: Recruiting Condition: Atherosclerosis

Study of T-PRED(TM) Compared to Pred Forte(R)
Status: Completed Condition: Cataract

A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.
Status: Completed Condition: Arthritis, Rheumatoid

A Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers
Status: Completed Condition: Healthy

Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive; Chronic Obstructive Pulmonary Disease (COPD)

A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets
Status: Withdrawn Condition: Therapeutic Equivalency

Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer
Status: Withdrawn Condition: Lung Cancer

Prevention of Noise-induced Hearing Loss
Status: Not yet recruiting Condition: Noise-induced Hearing Loss

A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions
Status: Withdrawn Condition: Therapeutic Equivalency

A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions
Status: Withdrawn Condition: Therapeutic Equivalency

Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome
Status: Completed Condition: Ovarian Hyperstimulation Syndrome

Prednisone and Acupuncture for the Treatment of Facial Neuritis: a Multiple Center, CER in China
Status: Recruiting Condition: Bell's Palsy

Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis
Status: Completed Condition: Allergic Conjunctivitis

Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma(MZL)
Status: Completed Condition: B-cell Lymphomas

Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
Status: Completed Condition: Endogenous Anterior Uveitis

Methylprednisolone Replacement for Dexamethasone-induced Hiccup
Status: Withdrawn Condition: Dexamethasone; Hiccup

Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer
Status: Recruiting Condition: Breast Cancer

Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification
Status: Recruiting Condition: Pseudophakia; Cataract Surgery

Topical Treatment of Uveitic Macular Edema
Status: Not yet recruiting Condition: Uveitis; Cystoid Macular Edema

Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Secondary Progressive Multiple Sclerosis
Status: Completed Condition: Multiple Sclerosis, Chronic Progressive

Prednisolone for Pain Reduction in Knee OA
Status: Completed Condition: Pain

Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia
Status: Completed Condition: Anemia, Hemolytic, Autoimmune

Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Status: Not yet recruiting Condition: Leprosy

Study of T-PRED(TM) Compared to Pred Forte(R) II
Status: Completed Condition: Cataract

Clinical Trial of Vincristine vs. Prednisolone for Treatment of Complicated Hemangiomas
Status: Terminated Condition: Hemangioma

Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses
Status: Recruiting Condition: Multiple Sclerosis, Relapsing-Remitting

Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care
Status: Completed Condition: Cataracts

Study to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse
Status: Recruiting Condition: Multiple Sclerosis

Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
Status: Completed Condition: Bursitis

Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas
Status: Recruiting Condition: Hemangioma of Infancy

Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
Status: Completed Condition: Open Angle Glaucoma

Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies
Status: Active, not recruiting Condition: Cataract

Safety, Pharmacokinetics and Pharmacodynamics Study With 2B3-201 in Healthy Subjects and Multiple Sclerosis(MS) Patients
Status: Recruiting Condition: Healthy Volunteers; Multiple Sclerosis

Ciclosporin in the Management of New Erythema Nodosum Leprosum
Status: Not yet recruiting Condition: Leprosy

Oral Prednisolone in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Status: Recruiting Condition: COPD Exacerbation

Phase 1 PK Interaction Study Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects
Status: Completed Condition: Drug Interactions

The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease
Status: Recruiting Condition: Behcet's Disease

Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache
Status: Completed Condition: Headache

Durolane Versus Methylprednisolone in Knee Osteoarthritis
Status: Completed Condition: Knee Osteoarthritis

Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis
Status: Completed Condition: Anterior Uveitis

Phase II Study of Simvastatin for Relapsed/Refractory Myeloma
Status: Withdrawn Condition: Myeloma

A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
Status: Completed Condition: Multiple Myeloma

Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
Status: Active, not recruiting Condition: Lymphoproliferative Disorder

Addition of Pyridoxine to Prednisolone in Infantile Spasms
Status: Recruiting Condition: Infantile Spasms

Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in Rheumatoid Arthritis
Status: Recruiting Condition: Progression of Rheumatoid Arthritis

A Study To Assess Safety And Effectiveness Of Medrol In Contact Dermatitis In Indian Patients
Status: Completed Condition: Dermatitis, Contact

Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection
Status: Completed Condition: Tendinopathy; Adrenal Insufficiency

Safety and Efficacy of Oral Mega Pulse Methylprednisolone in Severe Therapy Resistant Alopecia Areata
Status: Completed Condition: Alopecia Totalis; Alopecia Universalis; Ophiasic Alopecia

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
prednisolone acetate
SUSPENSION/DROPS;OPHTHALMIC017469Approved Prior to Jan 1, 1982RXNo<disabled><disabled>
prednisolone acetate
SUSPENSION/DROPS;OPHTHALMIC017100Approved Prior to Jan 1, 1982RXYes<disabled><disabled>
Bausch And Lomb
prednisolone acetate; sulfacetamide sodium
SUSPENSION/DROPS;OPHTHALMIC088089Dec 28, 1982DISCNNo<disabled><disabled>
prednisolone acetate; sulfacetamide sodium
SUSPENSION/DROPS;OPHTHALMIC088059Jul 29, 1983DISCNNo<disabled><disabled>
prednisolone acetate
SUSPENSION/DROPS;OPHTHALMIC017468Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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