boxed warning
For Oral Inhalation Only Levalbuterol Inhalation Solution (Concentrate) is only for use with a nebulizer. Dilute with sterile normal saline before use.
Application 207628
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | SOLUTION;INHALATION | EQ 0.25% BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207628-001 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE | SOLUTION / INHALATION | AN | 2017-01-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207628-001 | AN |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LEVALBUTEROL | LEVALBUTEROL | Aurobindo Pharma Limited | e1a9effb-6ef7-4651-b0ef-a9265600caff | 2023-10-31 | Boxed warning, Warnings, Adverse reactions |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
boxed warning
Instructions for Using Levalbuterol Inhalation Solution (Concentrate)
Warnings cross-check#
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warnings and cautions
5 WARNINGS AND PRECAUTIONS Life-threatening paradoxical bronchospasm may occur. Discontinue levalbuterol inhalation solution immediately and treat with alternative therapy. (5.1) Need for more doses of levalbuterol inhalation solution than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. (5.2) Levalbuterol inhalation solution is not a substitute for corticosteroids. (5.3) Cardiovascular effects may occur. Consider discontinuation of levalbuterol inhalation solution if these effects occur. Use with caution in patients with underlying cardiovascular disorders. (5.4) Excessive use may be fatal. Do not exceed recommended dose. (5.5) Immediate hypersensitivity reactions may occur. Discontinue levalbuterol inhalation solution immediately. (5.6) Hypokalemia and changes in blood glucose may occur. (5.7, 5.8) 5.1 Paradoxical Bronchospasm Levalbuterol inhalation solution can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, levalbuterol inhalation solution should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new vial. 5.2 Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of levalbuterol inhalation solution than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. 5.3 Use of Anti-Inflammatory Agents Levalbuterol inhalation solution is not a substitute for corticosteroids. The use of beta-adrenergic agonist alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen. 5.4 Cardiovascular Effects Levalbuterol inhalation solution, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and symptoms. Although such effects are uncommon after administration of levalbuterol inhalation solution at recommended doses, if they occur, the drug m...
Adverse reactions cross-check#
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adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Paradoxical bronchospasm [see Warnings and Precautions (5.1) ] Cardiovascular effects [see Warnings and Precautions (5.4) ] Immediate hypersensitivity reactions [see Warnings and Precautions (5.6) ] Hypokalemia [see Warnings and Precautions (5.8) ] Most common adverse reactions are: palpitations, chest pain, tachycardia, headache, dizziness, tremor and nervousness. (6) 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 the drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults and Adolescents 12 Years of Age and Older Adverse reaction information concerning levalbuterol inhalation solution in adults and adolescents is derived from one 4-week, multicenter, randomized, double-blind, active-, and placebo-controlled trial in 362 patients with asthma 12 years of age and older. Adverse reactions reported in ≥2% of patients receiving levalbuterol inhalation solution or racemic albuterol and more frequently than in patients receiving placebo are listed in Table 1. Table 1: Adverse Reactions Reported in a 4-Week, Controlled Clinical Trial in Adults and Adolescents ≥12 Years Old a One treatment group, racemic albuterol 1.25 mg, with 68 subjects is omitted. Percent of Patients a Body System Preferred Term Placebo (n=75) Levalbuterol Inhalation Solution 1.25 mg (n=73) Levalbuterol Inhalation Solution 0.63 mg (n=72) Racemic albuterol 2.5 mg (n=74) Body as a Whole Allergic reaction 1.3 0 0 2.7 Flu syndrome 0 1.4 4.2 2.7 Accidental injury 0 2.7 0 0 Pain 1.3 1.4 2.8 2.7 Back pain 0 0 0 2.7 Cardiovascular System Tachycardia 0 2.7 2.8 2.7 Migraine 0 2.7 0 0 Digestive System Dyspepsia 1.3 2.7 1.4 1.4 Musculoskeletal System Leg cramps 1.3 2.7 0 1.4 Central Nervous System Dizziness 1.3 2.7 1.4 0 Hypertonia 0 0 0 2.7 Nervousness 0 9.6 2.8 8.1 Tremor 0 6.8 0 2.7 Anxiety 0 2.7 0 0 Respiratory System Cough increased 2.7 4.1 1.4 2.7 Infection viral 9.3 12.3 6.9 12.2 Rhinitis 2.7 2.7 11.1 6.8 Sinusitis 2.7 1.4 4.2 2.7 Turbinate edema 0 1.4 ...
adverse reactions table
Table 1: Adverse Reactions Reported in a 4-Week, Controlled Clinical Trial in Adults and Adolescents ≥12 Years Olda One treatment group, racemic albuterol 1.25 mg, with 68 subjects is omitted. Percent of Patients aBody System Preferred Term Placebo (n=75) Levalbuterol Inhalation Solution 1.25 mg (n=73) Levalbuterol Inhalation Solution 0.63 mg (n=72) Racemic albuterol 2.5 mg (n=74) Body as a WholeAllergic reaction1.3002.7Flu syndrome01.44.22.7Accidental injury02.700Pain1.31.42.82.7Back pain0002.7Cardiovascular SystemTachycardia02.72.82.7Migraine02.700Digestive SystemDyspepsia1.32.71.41.4Musculoskeletal SystemLeg cramps1.32.701.4Central Nervous SystemDizziness1.32.71.40Hypertonia0002.7Nervousness09.62.88.1Tremor06.802.7Anxiety02.700Respiratory SystemCough increased2.74.11.42.7Infection viral9.312.36.912.2Rhinitis2.72.711.16.8Sinusitis2.71.44.22.7Turbinate edema01.42.80
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65862-942 | LEVALBUTEROL | LEVALBUTEROL | Aurobindo Pharma Limited | ANDA | Current |
| 65862-942 | LEVALBUTEROL | LEVALBUTEROL | Aurobindo Pharma Limited | ANDA | Current |
| 65862-942 | LEVALBUTEROL | LEVALBUTEROL | Aurobindo Pharma Limited | ANDA | Current |
| 65862-942 | LEVALBUTEROL | LEVALBUTEROL | Aurobindo Pharma Limited | ANDA | Current |