FDA Approves First Generic of Symbicort to Treat Asthma and COPD

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The FDA requires sponsors to submit appropriate data and information to demonstrate that complex generic drug-device combination products meet the agency’s rigorous approval standards. These standards ensure that generic drug products are as safe and effective as their brand name equivalents and meet the same high quality standards. The FDA regularly takes steps to help guide industry through the development process for generic drug products, including combination products, such as MDIs, that consist of a drug and a device. In June 2015, FDA published a PSG for budesonide and formoterol fumarate dihydrate inhalation aerosol. The FDA granted approval of this generic budesonide and formoterol fumarate dihydrate inhalation aerosol to Mylan Pharmaceuticals, Inc. People all over the world are living longer, healthier and more productive lives thanks to innovative medicines developed by companies like AstraZeneca.

At AstraZeneca, we believe it’s not enough for us to simply make medicines, we have to help ensure that the people who need our medicines have access to them. In fact, we’ve offered assistance programs for over 40 years, and we offer other programs and services to help people get the medicines they need. 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. Exhibit he appears to duplicate and the same kind of storylines, fashion and talk in the majority of his shows, that we is symbicort for asthma suppose is paying off as a result of high box-office grosses of the films and also the numerous award nominations as well. Convert and as a way to effectively Twist potential shows, register and what is symbicort inhaler used for insanity of the smoothness and the inherent depths have to be recognized.

Asthma impacts 25 million people, more than five million of whom are children, while COPD afflicts more than 16 million, according to the National Heart, Lung, and Blood Institute. Asthma is a chronic, long-term condition that affects the airways in the lungs, which can be worsened by physical activity and most often starts during childhood. COPD, which includes emphysema and chronic bronchitis, is a long-term, chronic disease that causes airflow blockage and makes it difficult to breathe. SYMBICORT is not used to relieve sudden breathing problems and will not replace a rescue inhaler. The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions about your condition, or if you would like more information about SYMBICORT, asthma, or COPD, talk to your doctor or pharmacist.

Complex products are medical products where uncertainty concerning the approval pathway or possible alternative approaches to product development can benefit from early scientific engagement, such as products with complex active ingredients and drug-device combination products. Since drug-device combination products can be more challenging to develop, fewer exist, resulting in less market competition. Addressing the challenges related to complex generics, and promoting more generic competition to these medicines, is a key part of the FDA’s Drug Competition Action Plan, and the agency’s efforts to promote patient access and more affordable medicines.

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Only you and your doctor can decide if SYMBICORT is right for you. If you do not have insurance coverage or your insurance does not cover SYMBICORT, you can expect to pay the amount determined by your pharmacy, which will vary.