Today, the US Food and Drug Administration has approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhaled aerosols for the treatment of two common lung health conditions. Maintenance treatment and alleviation of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and / or emphysema. This complex generic drug and device combination product, which is a metered dose inhaler, should not be used to treat acute asthma attacks.

“Today’s approval of the first generic drug for one of the most commonly prescribed complex drug and device combination products to treat asthma and COPD brings a copy of the complex drug generic drug to the market. It’s another step forward in our commitment to launching, which can improve quality of life and help reduce treatment costs, “said Dr. Sally Choe, Director of Generics and Drugs at the FDA Center for Drug Evaluation and Research. I am. “This reflects FDA’s ongoing efforts to increase competition and access to high-quality, safe, effective and affordable medicines for patients and consumers.”

Effects of asthma 25 million peopleMore than 5 million of them are children, COPD 16 millionaccording to National Institute of Cardiopulmonary Blood.. Asthma is a chronic, long-term condition that affects the airways of the lungs and can be exacerbated by physical activity, most often in childhood. It can cause wheezing (whistling when breathing), shortness of breath, and coughing. COPD, including emphysema and chronic bronchitis, is a long-term chronic disease that causes airflow obstruction and makes breathing difficult.

This drug-device combination product is a time-dose inhaler (MDI) that contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes airway muscles and improves breathing). )am. Two inhalations twice daily (usually morning and evening, about 12 hours apart) prevent symptoms such as wheezing in asthmatics and treat both disorders by improving breathing in COPD patients. .. The inhaler is approved for two strengths (160 / 4.5mcg / actuation and 80 / 4.5mcg / actuation).

The most common side effects of asthma patients associated with budesonide and formotelol dihydrate dihydrate oral inhalation aerosols are nasopharyngeal inflammation (swelling of the nasal passages and back of the throat), headache, upper respiratory tract infections, pharyngeal larynx (nasal). And mouth) pain, sinusitis, influenza. , Back pain, stuffy nose, stomach discomfort, vomiting, and oral candidiasis (thrush). The most common side effects for patients with COPD are nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infections.

The FDA regularly takes steps to guide the industry through the process of developing generic drugs, including combination products such as MDI, which consists of drugs and devices. To further accelerate the development of generic drugs and support the generic drug industry in this process, the FDA will explain the authorities’ current thinking and expectations on how to develop generic drugs that are therapeutically equivalent to their brand name. We publish unique guidance (PSG). Counterpart. In June 2015, the FDA PSG For inhaled aerosols of budesonide and formoterol fumarate dihydrate.

The FDA requires sponsors to provide appropriate data and information to demonstrate that complex generic drug and device combinations meet FDA’s strict approval criteria. These standards ensure that generics are as safe and effective as equivalent brand names and meet the same high quality standards.

Complex products can benefit from early scientific involvement, such as products containing complex active ingredients or drug-device combinations, with uncertainty about approval routes or possible alternative approaches to product development. It is a medical product. Drug and device combination products can be more difficult to develop, resulting in less existence and less market competition. Addressing the challenges associated with complex generic drugs and promoting more generic drug competition with these drugs can help. FDA Drug Competition Action PlanAnd the institution’s efforts to promote patient access and more affordable medicines.

The FDA has granted Mylan Pharmaceuticals, Inc approval for this generic budesonide and formoterol fumarate dihydrate inhalation aerosol.

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