BUDESONIDE

Product Type: HUMAN PRESCRIPTION DRUG

Route: RESPIRATORY (INHALATION)

Dosage Form:

NDC: 59651-585

Application: ANDA216667

Effective: 20231202

1 INDICATIONS AND USAGE Budesonide inhalation suspension is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use : Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.

2 DOSAGE AND ADMINISTRATION The recommended starting dose and highest recommended dose of budesonide inhalation suspension based on prior asthma therapy, are listed in the following table. Previous Therapy Recommended Starting Dose Highest Recommended Dose Bronchodilators alone 0.5 mg total daily dose administered either once daily or twice daily in divided doses 0.5 mg total daily dose Inhaled Corticosteroids 0.5 mg total daily dose administered either once daily or twice daily in divided doses 1 mg total daily dose Oral Corticosteroids 1 mg total daily dose administered either as 0.5 mg twice daily or 1 mg once daily 1 mg total daily dose Recommended dosing based on previous therapy ( 2 ). Start with the lowest recommended dose: Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily Oral corticosteroids: 0.5 mg twice daily or 1 mg once daily In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered If once-daily treatment does not provide adequate control, the total daily dose should be increased and/or administered as a divided dose. Once asthma stability is achieved, titrate the dose downwards For inhalation use via compressed air driven jet nebulizers only (not for use with ultrasonic devices). Not for injection. ( 2.2 ) 2.1 Dosing Recommendations Dosing recommendations based on previous therapy are as follows: Bronchodilators alone: 0.5 mg once daily or 0.25 mg twice daily Inhaled corticosteroids: 0.5 mg once daily or 0.25 mg twice daily up to 0.5 mg twice daily Oral corticosteroids: 0.5 mg twice daily or 1 mg once daily In symptomatic children not responding to non-steroidal therapy, a starting dose of 0.25 mg once daily may be considered. If once-daily treatment does not provide adequate control, the total daily dose should be increased and/or administered as a divided dose. In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved. 2.2 Directions for Use Budesonide inhalation suspension should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of budesonide inhalation suspension and, therefore, are NOT recommended. The effects of mixing budesonide inhalation suspension with other nebulizable medications have not been adequately assessed. Budesonide inhalation suspension should be administered separately in the nebulizer [see Patient Counseling Information (17.1) ] . A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver budesonide inhalation suspension to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of budesonide inhalation suspension delivered by other nebulizers and compressors have not been established.

4 CONTRAINDICATIONS The use of budesonide is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see Warnings and Precautions (5.3) , Description (11) , Adverse Reactions (6.2) ] . Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required ( 4 ) Hypersensitivity to any of the ingredients in budesonide ( 4 )

Not available.

6 ADVERSE REACTIONS Systemic and inhaled corticosteroid use may result in the following: Candida albicans Infection [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.3) ] Immunosuppression [see Warnings and Precautions (5.4) ] Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.6) ] Reduction in Bone Mineral Density [see Warnings and Precautions (5.7) ] Growth Effects in Pediatric Patients [see Warnings and Precautions (5.8) , Use in Specific Populations (8.4) ] Glaucoma, Increased Intraocular Pressure and Cataracts [see Warnings and Precautions (5.9) ] Eosinophilic Conditions and Churg-Strauss Syndrome [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence > 3%) are respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc., at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The incidence of common adverse reactions is based on three double-blind, placebo-controlled, randomized U.S. clinical trials in which 945 patients, 12 months to 8 years of age, (98 patients ≥12 months and <2 years of age; 225 patients ≥2 and <4 years of age; and 622 patients ≥4 and ≤8 years of age) were treated with budesonide (0.25 to 1 mg total daily dose for 12 weeks) or vehicle placebo. The incidence and nature of adverse events reported for budesonide was comparable to that reported for placebo. The following table shows the incidence of adverse events in U.S. controlled clinical trials, regardless of relationship to treatment, in patients previously receiving bronchodilators and/or inhaled corticosteroids. This population included a total of 605 male and 340 female patients and 78.4% were Caucasian, 13.8% African American, 5.5% Hispanic and 2.3% Other. Table 1 – Adverse Reactions occurring at an incidence of ≥3% in at least one active treatment group where the incidence was higher with budesonide than placebo Adverse Events Vehicle Placebo (n=227) % Budesonide Total Daily Dose 0.25 mg (n=178) % 0.5 mg (n=223) % 1 mg (n=317) % Respiratory System Disorder Respiratory Infection 36 34 35 38 Rhinitis 9 7 11 12 Coughing 5 5 9 8 Resistance Mechanism Disorders Otitis Media 11 12 11 9 Viral Infection 3 4 5 3 Moniliasis 2 4 3 4 Gastrointestinal System Disorders Gastroenteritis 4 5 5 5 Vomiting 3 2 4 4 Diarrhea 2 4 4 2 Abdominal Pain 2 3 2 3 Hearing and Vestibular Disorders Ear Infection 4 2 4 5 Platelet, Bleeding and Clotting Disorders Epistaxis 1 2 4 3 Vision Disorders Conjunctivitis 2 <1 4 2 Skin and Appendages Disorders Rash 3 <1 4 2 The information below includes all adverse reactions by system organ class with an incidence of 1 to < 3%, in at least one budesonide treatment group where the incidence was higher with budesonide than with placebo, regardless of relationship to treatment. Blood and lymphatic system disorders : cervical lymphadenopathy Ear and labyrinth disorders : earache General disorders and administration site conditions : fatigue, flu-like disorder Immune system disorders : allergic reaction Infections and infestations : eye infection, herpes simplex, external ear infection, infection Injury, poisoning and procedural complication : fracture Metabolism and nutrition disorders : anorexia Musculoskeletal and connective tissue disorders : myalgia Nervous system disorders : hyperkinesia Psychiatric disorders : emotional lability Respiratory, thoracic, and mediastinal disorders : chest pain, dysphonia, stridor Skin and subcutaneous tissue disorders : contact dermatitis, eczema, pustular rash, pruritus, purpura The incidence of reported adverse events was similar between the 447 budesonide-treated (mean total daily dose 0.5 to 1 mg) and 223 conventional therapy-treated pediatric asthma patients followed for one year in three open-label studies. 6.2 Postmarketing Experience The following adverse reactions have been reported during post-approval use of budesonide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Some of these adverse reactions may also have been observed in clinical studies with budesonide. Endocrine disorders: symptoms of hypocorticism and hypercorticism [see Warnings and Precautions (5.6) ] Eye disorders: cataracts, glaucoma, increased intraocular pressure [see Warnings and Precautions (5.9) ] General disorders and administration site conditions : fever, pain Immune system disorders : immediate and delayed hypersensitivity reactions including, anaphylaxis, angioedema, bronchospasm, rash, contact dermatitis, and urticaria [see Contraindications (4) , Warnings and Precautions (5.10) ] Infection and Infestation : sinusitis, pharyngitis, bronchitis Musculoskeletal and connective tissue disorders : avascular necrosis of the femoral head, osteoporosis, growth suppression Nervous system disorders : headache Psychiatric disorders : psychiatric symptoms including psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, and anxiety Respiratory, thoracic, and mediastinal disorders : cough, dysphonia and throat irritation Skin and subcutaneous tissue disorders : skin bruising, facial skin irritation Cases of growth suppression have been reported for inhaled corticosteroids including post-marketing reports for budesonide [see Warnings and Precautions (5.8) , Use in Specific Populations (8.4) ] .