Mar 15 2022
On March 15 2022, The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks.
COPD, which includes emphysema and chronic bronchitis, is a long-term, chronic disease that causes airflow blockage and makes it difficult to breathe.
This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing).
Two inhalations, two times a day (usually morning and night, about 12 hours apart), treat both diseases by preventing symptoms, such as wheezing for those with asthma, and by helping with better breathing, for those with COPD.
The inhaler is approved for two strengths (160/4.5 mcg/actuation and 80/4.5 mcg/actuation).
The FDA regularly takes steps to help guide industry through the development process for generic drug products, including combination products, such as MDIs, that consist of a drug and a device.
To further facilitate generic drug development, and to assist the generic pharmaceutical industry in this process, the FDA publishes product-specific guidances (PSGs) describing the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their brand name counterparts.
In June 2015, FDA published a PSG for budesonide and formoterol fumarate dihydrate inhalation aerosol.
The FDA requires sponsors to submit appropriate data and information to demonstrate that complex generic drug-device combination products meet the agency’s rigorous approval standards. These standards ensure that generic drug products are as safe and effective as their brand name equivalents and meet the same high quality standards.
Complex products are medical products where uncertainty concerning the approval pathway or possible alternative approaches to product development can benefit from early scientific engagement, such as products with complex active ingredients and drug-device combination products. Since drug-device combination products can be more challenging to develop, fewer exist, resulting in less market competition.
The FDA granted approval of this generic budesonide and formoterol fumarate dihydrate inhalation aerosol to Mylan Pharmaceuticals, Inc.
“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,”
“This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”
Sally Choe, Ph.D., director of the Office of Generic Drugs
in the FDA Center for Drug Evaluation and Research
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