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1. Veramyst
2. Avamys
3. 397864-44-7
4. Allermist
5. Furamist
6. Arnuity Ellipta
7. Ennhale
8. Gsk 685 698
9. Flonase Sensimist
10. Gw685698x
11. Gsk 685698
12. Gw-685698x
13. Js86977wnv
14. Chebi:74899
15. Gsk685968
16. Gsk-685968
17. Gw 685698x
18. [(6s,8s,9r,10s,11s,13s,14s,16r,17r)-6,9-difluoro-17-(fluoromethylsulfanylcarbonyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] Furan-2-carboxylate
19. Alisade
20. (6s,8s,9r,10s,11s,13s,14s,16r,17r)-6,9-difluoro-17-(((fluoromethyl)thio)carbonyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-17-yl Furan-2-carboxylate
21. Unii-js86977wnv
22. Fluticasone Furoate [usan:inn]
23. Fluticasonum Furoas
24. Veramyst (tn)
25. Furoate De Fluticasone
26. Furoato De Fluticasona
27. Fluticasone Furancarboxylate
28. Chembl1676
29. Schembl140504
30. Flonase Sensimist Allergy Relief
31. Fluticasone Furoate [mi]
32. Gtpl10892
33. Fluticasone Furoate [inn]
34. Fluticasone Furoate [jan]
35. Gw685698
36. Dtxsid401024827
37. Fluticasone Furoate [usan]
38. Fluticasone Furoate [vandf]
39. Bcp18136
40. Fluticasone Furoate [mart.]
41. Zinc3992105
42. Bdbm50354851
43. Fluticasone Furoate [who-dd]
44. S6487
45. Fluticasone Furoate (jan/usan/inn)
46. Fluticasone Furoate [ema Epar]
47. Db08906
48. Fluticasone Furoate [orange Book]
49. Hy-15234
50. Avamys Pound>> Veramyst Pound>> Allermist
51. Gw-685698
52. Cs-0003822
53. Drosta-1,4-dien-17-yl Furan-2-carboxylate
54. D06315
55. E86983
56. Breo Ellipta Component Fluticasone Furoate
57. Arnuity Ellipta Component Fluticasone Furoate
58. Fluticasone Furoate Component Of Breo Ellipta
59. Q2166700
60. Trelegy Ellipta Component Fluticasone Furoate
61. Fluticasone Furoate Component Of Arnuity Ellipta
62. Fluticasone Furoate Component Of Trelegy Ellipta
63. (6.alpha.,11.beta.,16.alpha.,17.alpha.)-6,9-difluoro-17-(((fluoro-methyl)thio)carbonyl)-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate
64. (6.alpha.,11.beta.,16.alpha.,17.alpha.)-6,9-difluoro-17-(((fluoromethyl)thio)carbonyl)-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furoate
65. (6.alpha.,11.beta.,16.alpha.,17.alpha.)-6,9-difluoro-17-(((fluoromethyl)thio)carbonyl)-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl-2-furancarboxylate
66. (6alpha,11alpha,14beta,16alpha,17alpha)-6,9-difluoro-17-{[(fluoromethyl)sulfanyl]carbonyl}-11-hydroxy-16-methyl-3-oxoan
67. (6alpha,11alpha,14beta,16alpha,17alpha)-6,9-difluoro-17-{[(fluoromethyl)sulfanyl]carbonyl}-11-hydroxy-16-methyl-3-oxoan Drosta-1,4-dien-17-yl Furan-2-carboxylate
68. (6alpha,11alpha,14beta,16alpha,17alpha)-6,9-difluoro-17-{[(fluoromethyl)sulfanyl]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl Furan-2-carboxylate
69. (6alpha,11beta,16alpha,17alpha)-6,9-difluoro-17-(((fluoromethyl)thio)carbonyl)-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl-2-furancarboxylate
70. 6.alpha.,9-difluoro-17-(((fluoromethyl)sulfanyl)carbonyl)-11.beta.-hydroxy-16.alpha.-methyl-3-oxoandrosta-1,4-dien-17.alpha.-yl Furan-2-carboxylate
71. 6alpha,9-difluoro-17-(((fluoromethyl)sulfanyl)carbonyl)-11beta-hydroxy-16alpha-methyl-3-oxoandrosta-1,4-dien-17alpha-yl Furan-2-carboxylate
72. 6alpha,9-difluoro-17beta-{[(fluoromethyl)sulfanyl]carbonyl}-11beta-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17alpha-yl 2-furoate
73. 911210-90-7
74. Androsta-1,4-diene-17-carbothioic Acid, 6,9-difluoro-17-((2- Furanylcarbonyl)oxy)-11-hydroxy-16-methyl-3-oxo-, S-(fluoromethyl) Ester, (6alpha,11beta,16alpha,17alpha)-
75. Androsta-1,4-diene-17-carbothioic Acid, 6,9-difluoro-17-((2- Furanylcarbonyl)oxy)-11-hydroxy-16-methyl-3-oxo-, S-(fluoromethyl) Ester, (6alpha,11beta,16alpha,17alpha)-
76. Androsta-1,4-diene-17-carbothioic Acid, 6,9-difluoro-17-((2-furanylcarbonyl)oxy)-11-hydroxy-16-methyl-3-oxo-, S-(fluoromethyl) Ester, (6.alpha.,11.beta.,16.alpha.,17.alpha.)-
77. Gw6
| Molecular Weight | 538.6 g/mol |
|---|---|
| Molecular Formula | C27H29F3O6S |
| XLogP3 | 4.8 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 6 |
| Exact Mass | 538.16369430 g/mol |
| Monoisotopic Mass | 538.16369430 g/mol |
| Topological Polar Surface Area | 119 Ų |
| Heavy Atom Count | 37 |
| Formal Charge | 0 |
| Complexity | 1080 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 9 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Veramyst |
| PubMed Health | Fluticasone |
| Drug Classes | Anti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Strong |
| Drug Label | Fluticasone furoate, the active component of VERAMYST Nasal Spray, is a synthetic fluorinated corticosteroid having the chemical name (6,11,16,17)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-... |
| Active Ingredient | Fluticasone furoate |
| Dosage Form | Spray, metered |
| Route | Nasal |
| Strength | 0.0275mg/inh |
| Market Status | Prescription |
| Company | Glaxosmithkline |
| 2 of 2 | |
|---|---|
| Drug Name | Veramyst |
| PubMed Health | Fluticasone |
| Drug Classes | Anti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Strong |
| Drug Label | Fluticasone furoate, the active component of VERAMYST Nasal Spray, is a synthetic fluorinated corticosteroid having the chemical name (6,11,16,17)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-... |
| Active Ingredient | Fluticasone furoate |
| Dosage Form | Spray, metered |
| Route | Nasal |
| Strength | 0.0275mg/inh |
| Market Status | Prescription |
| Company | Glaxosmithkline |
Fluticasone furoate is indicated as an inhaler for the treatment and management of asthma by prophylaxis. The fluticasone furoate nasal spray is indicated for treating season and perennial allergic rhinitis.
FDA Label
Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.
Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.
Systemically, in vitro experiments show fluticasone furoate activates glucocorticoid receptors, inhibits nuclear factor kappa b, and inhibits lung eosinophilia in rats.
R01AD12
R01AD12
R - Respiratory system
R01 - Nasal preparations
R01A - Decongestants and other nasal preparations for topical use
R01AD - Corticosteroids
R01AD12 - Fluticasone furoate
R - Respiratory system
R03 - Drugs for obstructive airway diseases
R03B - Other drugs for obstructive airway diseases, inhalants
R03BA - Glucocorticoids
R03BA09 - Fluticasone furoate
Absorption
Intranasal exposure of fluticasone furoate results in patients swallowing a larger portion of the dose. However, absorption is poor and metabolism is high, therefore there is negligible systemic exposure with a nasal bioavailability of 0.50% and oral bioavialability of 1.26%. Inhaled bioavailability is 13.9%. A study of 24 healthy Caucasian males showed an inhaled bioavailability of 6.3-18.4%.
Route of Elimination
Fluticasone furoate is eliminated 90% in the feces and 1-2% in the urine.
Volume of Distribution
608L at steady state for intravenous administration of fluticasone furoate. Other reports suggest the mean volume of distribution at steady state is 661L. A study of 24 healthy Caucasian males showed a volume of distribution at steady state of 704L following intravenous administration.
Clearance
57.8L/h for fluticasone furoate. A study of 24 healthy Caucasian males showed a clearance of 71.8L/h following intravenous administration.
Fluticasone furoate is cleared from hepatic metabolism by cytochrome P450 3A4. Fluticasone furoate is hydrolysed at the FIVE-S-fluoromethyl carbothioate group, forming an inactive metabolite.
15.1 hours for intranasal fluticasone furoate and 24 hours for the inhaled formulation. A study of 24 healthy Caucasian males showed a half life of 13.6 hours following intravenous administration and 17.3-23.9 hours followed inhalation.
Fluticasone furoate works through an unknown mechanism to affect the action of various cell types and mediators of inflammation. In vitro experiments show fluticasone furoate activating glucocorticoid receptors, inhibiting nuclear factor kappa b, and inhibiting lung eosinophilia in rats.

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A ARNUITY ELLIPTA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ARNUITY ELLIPTA, including repackagers and relabelers. The FDA regulates ARNUITY ELLIPTA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ARNUITY ELLIPTA API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A ARNUITY ELLIPTA DMF (Drug Master File) is a document detailing the whole manufacturing process of ARNUITY ELLIPTA active pharmaceutical ingredient (API) in detail. Different forms of ARNUITY ELLIPTA DMFs exist exist since differing nations have different regulations, such as ARNUITY ELLIPTA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ARNUITY ELLIPTA DMF submitted to regulatory agencies in the US is known as a USDMF. ARNUITY ELLIPTA USDMF includes data on ARNUITY ELLIPTA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ARNUITY ELLIPTA USDMF is kept confidential to protect the manufacturer’s intellectual property.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The ARNUITY ELLIPTA Drug Master File in Japan (ARNUITY ELLIPTA JDMF) empowers ARNUITY ELLIPTA API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the ARNUITY ELLIPTA JDMF during the approval evaluation for pharmaceutical products. At the time of ARNUITY ELLIPTA JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a ARNUITY ELLIPTA Drug Master File in Korea (ARNUITY ELLIPTA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ARNUITY ELLIPTA. The MFDS reviews the ARNUITY ELLIPTA KDMF as part of the drug registration process and uses the information provided in the ARNUITY ELLIPTA KDMF to evaluate the safety and efficacy of the drug.
After submitting a ARNUITY ELLIPTA KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their ARNUITY ELLIPTA API can apply through the Korea Drug Master File (KDMF).
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A ARNUITY ELLIPTA CEP of the European Pharmacopoeia monograph is often referred to as a ARNUITY ELLIPTA Certificate of Suitability (COS). The purpose of a ARNUITY ELLIPTA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ARNUITY ELLIPTA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ARNUITY ELLIPTA to their clients by showing that a ARNUITY ELLIPTA CEP has been issued for it. The manufacturer submits a ARNUITY ELLIPTA CEP (COS) as part of the market authorization procedure, and it takes on the role of a ARNUITY ELLIPTA CEP holder for the record. Additionally, the data presented in the ARNUITY ELLIPTA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ARNUITY ELLIPTA DMF.
A ARNUITY ELLIPTA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ARNUITY ELLIPTA CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A ARNUITY ELLIPTA written confirmation (ARNUITY ELLIPTA WC) is an official document issued by a regulatory agency to a ARNUITY ELLIPTA manufacturer, verifying that the manufacturing facility of a ARNUITY ELLIPTA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ARNUITY ELLIPTA APIs or ARNUITY ELLIPTA finished pharmaceutical products to another nation, regulatory agencies frequently require a ARNUITY ELLIPTA WC (written confirmation) as part of the regulatory process.
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing ARNUITY ELLIPTA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ARNUITY ELLIPTA API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture ARNUITY ELLIPTA as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain ARNUITY ELLIPTA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ARNUITY ELLIPTA NDC to their finished compounded human drug products, they may choose to do so.
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ARNUITY ELLIPTA Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
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A ARNUITY ELLIPTA CoA (Certificate of Analysis) is a formal document that attests to ARNUITY ELLIPTA's compliance with ARNUITY ELLIPTA specifications and serves as a tool for batch-level quality control.
ARNUITY ELLIPTA CoA mostly includes findings from lab analyses of a specific batch. For each ARNUITY ELLIPTA CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
ARNUITY ELLIPTA may be tested according to a variety of international standards, such as European Pharmacopoeia (ARNUITY ELLIPTA EP), ARNUITY ELLIPTA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ARNUITY ELLIPTA USP).