mometasone furoate and formoterol fumarate

FDA Drug Profile

Drug Details

Generic Name
mometasone furoate and formoterol fumarate
Brand Names
N/A
Application Number
Sponsor
Kindeva Drug Delivery L.P.
NDC Codes
3
Dosage Forms
AEROSOL
Routes
N/A
Active Ingredients
FORMOTEROL FUMARATE, MOMETASONE FUROATE

Indications and Usage

1 INDICATIONS AND USAGE DULERA is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: Treatment of asthma in patients 5 years of age and older. ( 1.1 ) Important Limitation of Use: Not indicated for the relief of acute bronchospasm. ( 1.1 ) 1.1 Treatment of Asthma DULERA is indicated for the twice-daily treatment of asthma in patients 5 years of age and older. DULERA 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: DULERA is NOT indicated for the relief of acute bronchospasm.