For Immediate Release: January 30, 2019

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The U.S. Food and Drug Administration today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Mylan obtained approval to market its generic inhaler 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.

“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. “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.”

According to the National Heart, Lung, and Blood Institute , asthma is a chronic lung disease that inflames and narrows the airways. Asthma causes recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath and coughing. The coughing often occurs at night or early in the morning. Asthma affects people of all ages, but it most often starts during childhood. In the United States, more than 26 million people are known to have asthma, about seven million of these people are children. COPD is a progressive lung disease that makes it hard to breathe and may become worse over time. COPD can cause coughing that produces large amounts of mucus, wheezing, shortness of breath, chest tightness and other symptoms.

“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. “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.”

Inhalers are known as “combination products” because they consist of a drug and a device. The development of generic combination products can be more challenging than, for instance, solid oral dosage forms, like tablets, and the FDA regularly takes steps to help guide industry through the process. The FDA recognizes the 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.

Under GDUFA II, individual companies can meet with the FDA as part of their pre-ANDA program to support their development of such complex products. The FDA also publishes publicly available guidance documents describing the steps the FDA recommends companies take to submit complete, approvable applications for various types of drug products.

In 2013, the FDA issued a draft product specific guidance for proposed generic drug products referencing Advair Diskus, which, among other things, provides bioequivalence recommendations, as well as formulation and device considerations. Further, as with brand-name drugs, the FDA inspects manufacturing and packaging facilities for generic drugs to ensure that they are capable of consistently producing quality products.

The FDA requires appropriate data and information to demonstrate that complex generic drug-device combination products meet the agency’s rigorous approval standards to ensure quality drug products that are as safe and effective as their brand name counterparts are available to patients.

The most common side effects associated with fluticasone propionate and salmeterol inhalation powder for the treatment of asthma include 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. For the treatment of COPD the most common side effects are pneumonia, oral candidiasis, throat irritation, hoarse voice or trouble speaking (dysphonia), viral respiratory infections, headaches and musculoskeletal pain.

The FDA continues to advance new policies to promote more generic competition for complex drugs. Recently, the FDA issued 27 guidance documents to help advance the development of generic transdermal and topical delivery systems. The agency also intends to issue an umbrella guidance to help generic drug developers address some of the most challenging regulatory and scientific issues that may be encountered during the development of complex drugs.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Inquiries Media: Lyndsay Meyer 240-402-5345 Consumer: 888-INFO-FDA

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