On August 12, 2019, the FDA approved Merck's Dulera (mometasone furoate/ formoterol fumarate dihydrate) inhalation aerosol, for the twice-daily treatment of asthma in patients 5 years of age and older.

Is Dulera FDA approved?

The FDA approval of Dulera was partially based on two randomized clinical trials (Trial 1, Trial 2). These trials enrolled a total of 1,509 patients 12 years of age and older with persistent asthma uncontrolled on medium or high dose inhaled corticosteroids.

Is Dulera still on the market?

There is currently no therapeutically equivalent version of Dulera available in the United States. Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Dulera. These medications may be counterfeit and potentially unsafe.