The FDA said it is the first approval for 'one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD.'
“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research.
According to the FDA, 25 million people are affected by asthma while 16 million people have COPD - chronic obstructive pulmonary disease. The FDA said approval for the metered-dose inhaler was granted to Mylan Pharmaceuticals. The inhaler contains “budesonide and formoterol .” Two inhalations a day, the FDA said, treats both diseases by preventing symptoms. It is approved for two strengths.
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