Arformoterol Tartrate Inhalation Solution

FDA Drug Profile — Arformoterol Tartrate Inhalation Solution

Drug Details

Generic Name
Arformoterol Tartrate Inhalation Solution
Brand Names
Arformoterol Tartrate Inhalation Solution
Application Number
ANDA214736
Sponsor
Ritedose Pharmaceuticals, LLC
NDC Codes
1
Dosage Forms
SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients
ARFORMOTEROL TARTRATE

Indications and Usage

1. INDICATIONS AND USAGE Arformoterol Tartrate Inhalation Solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1) Important limitations of use: Arformoterol Tartrate Inhalation Solution is not inidcated to treat acute deteriorations of chronic obstructive pulmonary disease. (1.2, 5.2) Arformoterol Tartrate Inhalation Solution is not indicated to treat asthma. (1.2) 1.1 Maintenance Treatment of COPD Arformoterol Tartrate Inhalation Solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Arformoterol Tartrate Inhalation Solution is for use by nebulization only. 1.2 Important Limitations of Use Arformoterol Tartrate Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see Warnings and Precautions (5.2)] . Arformoterol Tartrate Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of Arformoterol Tartrate Inhalation Solution in asthma have not been established.