fluticasone propionate and salmeterol
fluticasone propionate and salmeterol is listed in the FDA National Drug Code directory with 35 NDC codes, marketed under brand names including Fluticasone Propionate and Salmeterol, Fluticasone Propionate and Salmeterol DISKUS, fluticasone propionate and salmeterol. Available dosage form: powder.
Drug Details
- Generic Name
- fluticasone propionate and salmeterol
- Brand Names
- Fluticasone Propionate and Salmeterol, Fluticasone Propionate and Salmeterol DISKUS, fluticasone propionate and salmeterol, ADVAIR DISKUS, Wixela Inhub
- Application Number
- ANDA214464
- Sponsor
- Lannett Company, Inc.
- NDC Codes
- 35
- Dosage Forms
- POWDER
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE
Indications and Usage
1 INDICATIONS AND USAGE Wixela Inhub ® is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: • Twice-daily treatment of asthma in patients aged 4 years and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). ( 1.2 ) Important limitation of use: Not indicated for relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma Wixela Inhub ® is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Wixela Inhub ® should be used for patients not adequately controlled on a long-term asthma control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA). Important Limitation of Use Wixela Inhub ® is NOT indicated for the relief of acute bronchospasm. 1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease Wixela Inhub ® 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Wixela Inhub ® 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. Wixela Inhub ® 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength Wixela Inhub ® 500/50 over Wixela Inhub ® 250/50 has not been demonstrated. Important Limitation of Use Wixela Inhub ® is NOT indicated for the relief of acute bronchospasm.