The U.S. Food and Drug Administration (FDA) approved the first generic Advair Diskus inhaler to treat asthma and chronic obstructive pulmonary disease (COPD).
FDA approved this Advair Diskus (fluticasone propionate and salmeterol inhalation powder) on 30 January 2019, for the treatment of asthma in patients aged 4 years and above. Advair Diskus can also be used for the maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD.
Inhalers are a combination of a drug and a device which delivers medication into the body through the lungs. This Advair Diskus inhaler is now allowed to be sold in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg.
According to National Heart, Lung and Blood Institute, asthma is a chronic disease that affects the lungs and causes chest tightness, recurring periods of wheezing (a whistling sound when you breathe), shortness of breath and coughing. Usually, it is seen that asthma patients acquire this disease from childhood but it can happen in later stages of age too.
On the other hand, COPD is also a lung disease that makes breathing really hard for the patient. COPD causes coughing that produces large amounts of mucus, wheezing, shortness of breath, chest tightness and other symptoms.
“Today’s approval of the first generic drug product for one of the most commonly prescribed asthma and COPD inhalers in the U.S. is part of our longstanding commitment to advance access to lower cost, high-quality generic alternatives,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
He added, “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”
“The FDA recognizes challenges companies face when seeking to develop hard-to-copy complex generics, such as drug-device combination products, including when the drugs are incorporated into inhalation devices like this,” said Anna Abram, FDA’s Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
She also said, “We are committed to advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many applications covering proposed generic complex products for which a generic has not yet been approved.”
According to Lung India journal, approximately 358.2 million (35.82 crores) people were affected by Bronchial asthma in 2015 in India. Also, as mentioned in Journal of Thoracic Disease, the number of COPD deaths in India in 2011 was 5,56,000.
The patients before consuming the drug must take diligent care of the fact that it carries a few side effects also. Fluticasone propionate and salmeterol inhalation powder may cause upper respiratory tract infection or inflammation, swelling in the back of the throat (pharyngitis), hoarse voice or trouble speaking (dysphonia), oral candidiasis, bronchitis, cough, headaches, nausea and vomiting in asthma patients.
In COPD patients, the inhalation powder may cause pneumonia, oral candidiasis, throat irritation, hoarse voice or trouble speaking (dysphonia), viral respiratory infections, headaches, and musculoskeletal pain.