Approval of Generic Fluticasone Propionate/Salmeterol Xinafoate Dry Powder Inhalers in the US: A Difficult Exercise in Regulatory Science

Pharmaceutical Medicine ◽

10.1007/s40290-014-0065-3 ◽

2014 ◽

Vol 28 (4) ◽

pp. 169-173

Author(s):

Anders Fuglsang

Keyword(s):

Fluticasone Propionate ◽

Regulatory Science ◽

Dry Powder Inhalers ◽

Salmeterol Xinafoate ◽

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HPTLC-densitometric method for simultaneous determination of salmeterol xinafoate and fluticasone propionate in dry powder inhalers

Saudi Pharmaceutical Journal ◽

10.1016/j.jsps.2010.05.001 ◽

2010 ◽

Vol 18 (3) ◽

pp. 153-159 ◽

Author(s):

Lantider Kasaye ◽

Ariaya Hymete ◽

Abdel-Maaboud I. Mohamed

Keyword(s):

Fluticasone Propionate ◽

Simultaneous Determination ◽

Dry Powder Inhalers ◽

Salmeterol Xinafoate

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Comparative Pulmonary Function and Pharmacokinetics of Fluticasone Propionate and Salmeterol Xinafoate Delivered by Two Dry Powder Inhalers to Patients with Asthma

Journal of Aerosol Medicine and Pulmonary Drug Delivery ◽

10.1089/jamp.2011.0884 ◽

2011 ◽

Vol 24 (5) ◽

pp. 245-252 ◽

Author(s):

Lester I. Harrison ◽

Christopher C. Novak ◽

Michael J. Needham ◽

Paul Ratner

Keyword(s):

Fluticasone Propionate ◽

Pulmonary Function ◽

Dry Powder Inhalers ◽

Salmeterol Xinafoate

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Optimized particle engineering of fluticasone propionate and salmeterol xinafoate by spray drying technique for dry powder inhalation

Advanced Powder Technology ◽

10.1016/j.apt.2016.10.022 ◽

2017 ◽

Vol 28 (2) ◽

pp. 534-542 ◽

Author(s):

Faezeh Khandouzi ◽

Zahra Daman ◽

Kambiz Gilani

Keyword(s):

Fluticasone Propionate ◽

Spray Drying ◽

Particle Engineering ◽

Dry Powder Inhalation ◽

Salmeterol Xinafoate

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Efficacy And Safety Evaluation Of A Dry Powder Inhaler Containing Salmeterol Xinafoate 25 Mcg/Fluticasone Propionate 250 Mcg In Subjects With Asthma: A Randomized, Open Label, Comparative, Active Controlled, Parallel Groups, And Multi-Centric Study.

The Internet Journal of Asthma Allergy and Immunology ◽

10.5580/22b1 ◽

2011 ◽

Vol 7 (2) ◽

Keyword(s):

Fluticasone Propionate ◽

Dry Powder Inhaler ◽

Safety Evaluation ◽

Efficacy And Safety ◽

Salmeterol Xinafoate

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Dry Powder Formulations for Inhalation of Fluticasone Propionate and Salmeterol Xinafoate Microcrystals

Journal of Pharmaceutical Sciences ◽

10.1002/jps.21450 ◽

2009 ◽

Vol 98 (2) ◽

pp. 503-515 ◽

Author(s):

Darragh Murnane ◽

Gary P. Martin ◽

Christopher Marriott

Keyword(s):

Fluticasone Propionate ◽

Salmeterol Xinafoate ◽

Dry Powder Formulations

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HPLC method for simultaneous determination of salmeterol xinafoate and fluticasone propionate for the quality control of dry powder inhalation products

Acta Chromatographica ◽

10.1556/achrom.27.2015.2.8 ◽

2015 ◽

Vol 27 (2) ◽

pp. 309-320 ◽

Author(s):

E. Pączkowska ◽

D. Smukowska ◽

E. Tratkiewicz ◽

P. Białasiewicz

Keyword(s):

Quality Control ◽

Fluticasone Propionate ◽

Simultaneous Determination ◽

Hplc Method ◽

Dry Powder Inhalation ◽

Salmeterol Xinafoate

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Randomized, double-blind trial evaluating the efficacy and safety of fluticasone propionate and fluticasone propionate/salmeterol delivered via multidose dry powder inhalers in patients with persistent asthma aged 12 years and older

Journal of Asthma ◽

10.1080/02770903.2017.1350971 ◽

2017 ◽

Vol 55 (6) ◽

pp. 640-650 ◽

Author(s):

Gordon Raphael ◽

Gloria Yiu ◽

Anat Sakov ◽

Siyu Liu ◽

Cynthia Caracta

Keyword(s):

Fluticasone Propionate ◽

Persistent Asthma ◽

Dry Powder Inhalers ◽

Double Blind Trial ◽

Efficacy And Safety ◽

Double Blind ◽

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Pharmacokinetics of Salmeterol and Fluticasone Propionate Delivered in Combination via Easyhaler and Diskus Dry Powder Inhalers in Healthy Subjects

Journal of Aerosol Medicine and Pulmonary Drug Delivery ◽

10.1089/jamp.2017.1437 ◽

2018 ◽

Vol 31 (5) ◽

pp. 290-297 ◽

Author(s):

Merja Kirjavainen ◽

Leena Mattila ◽

Mikko Vahteristo ◽

Jani Korhonen ◽

Satu Lähelmä

Keyword(s):

Fluticasone Propionate ◽

Healthy Subjects ◽

Dry Powder Inhalers ◽

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P209 Fluticasone propionate and fluticasone/salmeterol multidose dry powder inhalers in patients previously treated through alternative devices

Annals of Allergy Asthma & Immunology ◽

10.1016/j.anai.2017.08.247 ◽

2017 ◽

Vol 119 (5) ◽

pp. S52

Author(s):

D. Bernstein ◽

C. Small ◽

G. Yiu ◽

S. Stoyanov

Keyword(s):

Fluticasone Propionate ◽

Dry Powder Inhalers ◽

Previously Treated

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Patient-Reported Outcomes and Quality of Life Improved with Fluticasone Propionate and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhalers Versus Placebo in Patients with Persistent Asthma

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2016.12.086 ◽

2017 ◽

Vol 139 (2) ◽

pp. AB10

Author(s):

Gordon Raphael ◽

Gloria Yiu ◽

Anat Sakov ◽

Siyu Liu ◽

Cynthia Caracta

Keyword(s):

Quality Of Life ◽

Fluticasone Propionate ◽

Patient Reported Outcomes ◽

Persistent Asthma ◽

Dry Powder Inhalers ◽

Patient Reported

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