1 INDICATIONS AND USAGE Formoterol fumarate inhalation solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

( 1.1 ) Important limitations of use: Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease.

( 1.2 , 5.2 ) Formoterol fumarate inhalation solution is not indicated to treat asthma.

( 1.2 ) 1.1 Maintenance Treatment of COPD Formoterol fumarate inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

1.2 Important Limitations of Use Formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see WARNINGS AND PRECAUTIONS ( 5.2 )].

Formoterol fumarate inhalation solution is not indicated to treat asthma.

The safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established.

6 ADVERSE REACTIONS Long-acting beta 2 -adrenergic agonists, such as formoterol fumarate, as monotherapy (without an inhaled corticosteroid) for asthma increase the risk of asthma-related events.

Formoterol fumarate is not indicated for the treatment of asthma [see WARNINGS AND PRECAUTIONS ( 5.1 )].

Most common adverse reactions ( > 2% and more common than placebo) are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc., at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Beta 2 -Agonist Adverse Reaction Profile Adverse reactions to formoterol fumarate inhalation solution are expected to be similar in nature to other beta 2 -adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, muscle cramps, palpitations, nausea, dizziness, fatigue, malaise, insomnia, hypokalemia, hyperglycemia, and metabolic acidosis.

6.2 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults with COPD The data described below reflect exposure to formoterol fumarate inhalation solution 20 mcg twice daily by oral inhalation in 586 patients, including 232 exposed for 6 months and 155 exposed for at least 1 year.

Formoterol fumarate inhalation solution was studied in a 12-week, placebo-and active-controlled trial (123 subjects treated with formoterol fumarate inhalation solution) and a 52-week, active-controlled trial (463 subjects treated with formoterol fumarate inhalation solution).

Patients were mostly Caucasians (88%) between 40 to 90 years old (mean, 64 years old) and had COPD, with a mean FEV 1 of 1.33 L.

Patients with significant concurrent cardiac and other medical diseases were excluded from the trials.

Table 1 shows adverse reactions from the 12-week, double-blind, placebo-controlled trial where the frequency was greater than or equal to 2% in the formoterol fumarate inhalation solution group and where the rate in the formoterol fumarate inhalation solution group exceeded the rate in the placebo group.

In this trial, the frequency of patients experiencing cardiovascular adverse events was 4.1% for formoterol fumarate inhalation solution and 4.4% for placebo.

There were no frequently occurring specific cardiovascular adverse events for formoterol fumarate inhalation solution (frequency greater than or equal to 1% and greater than placebo).

The rate of COPD exacerbations was 4.1% for formoterol fumarate inhalation solution and 7.9% for placebo.

TABLE 1 Number of patients with adverse reactions in the 12-week multiple-dose controlled clinical trial Adverse Reaction Formoterol Fumarate Inhalation Solution 20 mcg Placebo n (%) n (%) Total Patients 123 (100) 114 (100) Diarrhea 6 (4.9) 4 (3.5) Nausea 6 (4.9) 3 (2.6) Nasopharyngitis 4 (3.3) 2 (1.8) Dry Mouth 4 (3.3) 2 (1.8) Vomiting 3 (2.4) 2 (1.8) Dizziness 3 (2.4) 1 (0.9) Insomnia 3 (2.4) 0 0 Patients treated with formoterol fumarate inhalation solution 20 mcg twice daily in the 52-week open-label trial did not experience an increase in specific clinically significant adverse events above the number expected based on the medical condition and age of the patients.

6.3 Postmarketing Experience The following adverse reactions have been reported during post-approval use of formoterol fumarate inhalation solution.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Anaphylactic reactions, urticaria, angioedema (presenting as face, lip, tongue, eye, pharyngeal, or mouth edema), rash, and bronchospasm