ciclesonide

FDA Drug Profile — Omnaris, Alvesco

Drug Details

Generic Name
ciclesonide
Brand Names
Omnaris, Alvesco
Application Number
NDA022004
Sponsor
Covis Pharma US, Inc
NDC Codes
3
Dosage Forms
SPRAY, AEROSOL, METERED
Routes
NASAL, RESPIRATORY (INHALATION)
Active Ingredients
CICLESONIDE

Indications and Usage

1 INDICATIONS AND USAGE ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use : ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age. ALVESCO is an inhaled corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. ( 1 ) Limitations of Use : ALVESCO is not indicated for the relief of acute bronchospasm or in pediatric patients less than 12 years of age. ( 1 )