First Generic of Symbicort (Budesonide and Formoterol Fumarate Dihydrate) Receives FDA Approval

Summary :

The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol to treat asthma in patients 6 years and older and for maintenance treatment in patients with chronic obstructive pulmonary disease (COPD), the agency announced March 15.

The FDA notes that the generic metered-dose inhaler should not be used to treat acute asthma attacks. For the COPD indication, the generic is approved for maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic bronchitis and/or emphysema.

The drug-device combination product, which contains both budesonide and formoterol fumarate dihydrate, should be administered as two inhalations two times per day about 12 hours apart to prevent symptoms such as wheezing in asthma and to improve breathing in COPD. Two strengths of the inhaler have been approved: 160/4.5 mcg/actuation and 80/4.5 mcg/actuation.

Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol

API – Budesonide and Formoterol fumarate dihydrate

About Formoterol fumarate dihydrate

• Formoterol is a long-acting bronchodilator used as a long-term (maintenance) treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema).
• It should only be used long-term if your asthma symptoms are not controlled by your other asthma medications (such as inhaled corticosteroids).
• Formoterol must not be used alone to treat asthma

Inhaled formoterol works like other β₂ agonists,causing bronchodilation by relaxing the smooth muscle in the airway so as to treat the exacerbation of asthma.

About Budesonide

• Budesonide is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma.
• Budesonide powder for oral inhalation   is used in adults and children 6 years of age and older. Budesonide suspension (liquid) for oral inhalation is used in children 12 months to 8 years of age.
• Budesonide belongs to a class of medications called corticosteroids.
• It works by decreasing swelling and irritation in the airways to allow for easier breathing.

Budesonide is a potent topical anti-inflammatory agent. It binds and activates glucocorticoid receptors (GR) in the effector cell (e.g., bronchial) cytoplasm that allows the translocation of this budesonide-GR complex in the bronchi nucleus, which binds to both HDCA2 and CBP (HAT)

For those with asthma, the most commonly reported side effects with budesonide and formoterol fumarate dihydrate oral inhalation aerosol are nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis. For those with COPD, commonly reported side effects include nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection.

Approval of the generic budesonide and formoterol fumarate dihydrate inhalation aerosol was granted to Mylan Pharmaceuticals Inc.

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