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Indacaterol
Indacaterol is an ultra- long-acting beta-adrenoceptor agonist developed by Novartis. It needs to be taken only once a day, unlike the related drugs formoterol and salmeterol. It is licensed only for the treatment of chronic obstructive pulmonary disease (COPD) (long-term data in patients with asthma are thus far lacking). It is delivered through a dry powder inhaler. Medical uses A Cochrane review found benefit in lung function in people with COPD at least as good as that seen with twice-daily long-acting beta2-agonists. History It was approved by the European Medicines Agency (EMA) under the brand name Onbrez Breezhaler on November 30, 2009, and by the United States Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ... (FDA), under the brand name Arca ...
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Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is a type of progressive lung disease characterized by chronic respiratory symptoms and airflow limitation. GOLD defines COPD as a heterogeneous lung condition characterized by chronic respiratory symptoms (shortness of breath, cough, sputum production or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) or alveoli ( emphysema) that cause persistent, often progressive, airflow obstruction. The main symptoms of COPD include shortness of breath and a cough, which may or may not produce mucus. COPD progressively worsens, with everyday activities such as walking or dressing becoming difficult. While COPD is incurable, it is preventable and treatable. The two most common types of COPD are emphysema and chronic bronchitis and have been the two classic COPD phenotypes. However, this basic dogma has been challenged as varying degrees of co-existing emphysema, chronic bronchitis, and potentially significan ...
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European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would ...
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Novartis
Novartis AG is a Swiss multinational corporation, multinational pharmaceutical company, pharmaceutical corporation based in Basel, Switzerland. Novartis is one of the largest pharmaceutical companies in the world and was the eighth largest by revenue in 2024. Novartis manufactures the drugs clozapine (Clozaril), diclofenac (Voltaren; sold to GlaxoSmithKline in 2015 deal), carbamazepine (Tegretol), valsartan (Diovan), imatinib mesylate (Gleevec/Glivec), cyclosporine (Neoral/Sandimmune), letrozole (Femara), methylphenidate (Ritalin; produced by Sandoz since 2023), terbinafine (Lamisil), deferasirox (Exjade), and others. Novartis was formed in 1996 by the merger of Ciba-Geigy and Sandoz. It was considered the largest corporate merger in history during that time. The pharmaceutical and agrochemical divisions of both companies formed Novartis as an independent entity. The name Novartis was based on the Latin terms, ''novae artes'' (new skills). After the merger, other Ciba-Geigy and ...
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Formoterol
Formoterol, also known as eformoterol, is a long-acting β2 agonist (LABA) used as a bronchodilator in the management of asthma and chronic obstructive pulmonary disease (COPD). Formoterol has an extended duration of action (up to 12 h) compared to short-acting β2 agonists such as salbutamol (albuterol), which are effective for 4 h to 6 h. Formoterol has a relatively rapid onset of action compared to other LABAs, and is effective within 2-3 minutes. The 2022 Global Initiative for Asthma report recommends a combination formoterol/inhaled corticosteroid inhaler as both a preventer and reliever treatment for asthma in adults. In children, a short-acting β2 adrenergic agonist (e.g., salbutamol) is still recommended. It was patented in 1972 and came into medical use in 1998. It is available as a generic medication. It is also marketed in the combination formulations budesonide/formoterol and mometasone/formoterol. Side effects In November 2005, the US Foo ...
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Salmeterol
Salmeterol is a Long-acting beta-adrenoceptor agonist, long-acting β2 adrenergic receptor agonist (LABA) used in the treatment and prevention of asthma symptoms and control of chronic obstructive pulmonary disease (COPD) symptoms. Symptoms of bronchospasm include Dyspnea, shortness of breath, Wheeze, wheezing, coughing and chest tightness. It is also used to prevent breathing difficulties during exercise (exercise-induced bronchoconstriction). It was patented in 1983 and came into medical use in 1990. It is marketed as Serevent in the US. It is available as a dry-powder inhaler (DPI) that releases a powdered form of the drug. It was previously available as a metered-dose inhaler (MDI) but was discontinued in the US in 2002. It is available as an MDI in other countries as of 2020. Mechanism of action Inhaled salmeterol belongs to a group of drugs called Beta-2 Agonists, beta-2 agonists. These drugs stimulate Beta-2 adrenergic receptor, beta-2 receptors present in the bronchia ...
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Asthma
Asthma is a common long-term inflammatory disease of the airways of the lungs. It is characterized by variable and recurring symptoms, reversible airflow obstruction, and easily triggered bronchospasms. Symptoms include episodes of wheezing, coughing, chest tightness, and shortness of breath. A sudden worsening of asthma symptoms sometimes called an 'asthma attack' or an 'asthma exacerbation' can occur when allergens, pollen, dust, or other particles, are inhaled into the lungs, causing the bronchioles to constrict and produce mucus, which then restricts oxygen flow to the alveoli. These may occur a few times a day or a few times per week. Depending on the person, asthma symptoms may become worse at night or with exercise. Asthma is thought to be caused by a combination of genetic and environmental factors. Environmental factors include exposure to air pollution and allergens. Other potential triggers include medications such as aspirin and beta blockers. Diag ...
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Dry Powder Inhaler
A dry-powder inhaler (DPI) is a device that delivers medication to the lungs in the form of a dry powder. DPIs are commonly used to treat respiratory diseases such as asthma, bronchitis, emphysema and Chronic obstructive pulmonary disease, COPD although DPIs (such as inhalable insulin) have also been used in the treatment of diabetes mellitus. DPIs are an alternative to the aerosol-based inhalers commonly called metered-dose inhaler (or MDI). The DPIs may require some procedure to allow a measured dose of powder to be ready for the patient to take. The medication is commonly held either in a capsule for manual loading or in a proprietary form inside the inhaler. Once loaded or actuated, the operator puts the mouthpiece of the inhaler into their mouth and takes a sharp, deep inhalation (ensuring that the medication reaches the lower parts of the lungs), holding their breath for 5–10 seconds. There are a variety of such devices. The dose that can be delivered is typically less ...
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United States Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ...
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Sunovion
On July 1, 2023, Sunovion Pharmaceuticals Inc. became part of Sumitomo Pharma America, Inc., a biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry and neurology, oncology, urology, women's health, rare disease, and cell and gene therapies. Sunovion was founded as Sepracor, Inc. in 1984 by Timothy J. Barberich, Steve Matson, and Bob Bratzler. Sepracor completed its initial public offering in 1991, trading on NASDAQ under the ticker SEPR. On October 12, 2010, Sepracor, Inc. was acquired by and became a standalone subsidiary of Sumitomo Pharma of Japan (then known as Sumitomo Dainippon Pharma). In April 2023, Sumitomo Pharma announced the combination of its U.S. subsidiaries, including Sunovion, to form Sumitomo Pharma America (SMPA). Company history Sepracor completed its initial public offering in 1991 at a market cap of $160M. The company's initial focus was on the separation and purific ...
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Phenylethanolamines
Phenylethanolamine (sometimes abbreviated PEOH), or β-hydroxyphenethylamine, is a trace amine with a structure similar to those of other trace phenethylamines as well as the catecholamine neurotransmitters dopamine, norepinephrine, and epinephrine. As an organic compound, phenylethanolamine is a β-hydroxylated phenethylamine that is also structurally related to a number of synthetic drugs in the substituted phenethylamine class. In common with these compounds, phenylethanolamine has strong cardiovascular activity and, under the name ''Apophedrin'', has been used as a drug to produce topical vasoconstriction.''The Merck Index, 10th Ed.'' (1983), p. 1051, Merck & Co., Rahway. In appearance, phenylethanolamine is a white solid. Phenylethanolamine is perhaps best known in the field of bioscience as part of the enzyme name " phenylethanolamine N-methyl transferase", referring to an enzyme which is responsible for the conversion of norepinephrine into epinephrine, as well as other r ...
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