Novartis has announced FDA approval for the Seebri Neohaler glycopyrrolate DPI and the Utibron Neohaler indacaterol/glycopyrrolate DPI for the treatment of COPD. According to the company, both inhalers should be available in the first quarter of 2016. The company's indacaterol monotherapy DPI, marketed in the US as Arcapta Neohaler, was approved by the FDA in … [Read more...] about FDA approves Utibron and Seebri Neohaler DPIs
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AstraZeneca launches Duaklir Genuair in Canada
AstraZeneca Canada has announced the availability of the Duaklir Genuair aclidinium bromide/formoterol fumarate DPI in Canada for the treatment of COPD. Health Canada issued a Notice of Compliance for Duaklir Genuair on April 2, 2015. AstraZeneca acquired Canadian rights to Duaklir Genuair from Actavis in February 2015. In Europe, the inhaler was approved for the … [Read more...] about AstraZeneca launches Duaklir Genuair in Canada
GSK announces that Advair Diskus meets primary endpoint in safety study
GlaxoSmithKline has announced results from the 26-week AUSTRI postmarketing study comparing the safety of Advair Diskus fluticasone propionate/salmeterol DPI to fluticasone propionate monotherapy for the treatment of asthma. According to GSK, the study demonstrated that Advair Diskus was non-inferior to FP at three different dosage strengths for the risk of serious … [Read more...] about GSK announces that Advair Diskus meets primary endpoint in safety study
Glenmark makes deal with Celon to market fluticasone/salmeterol DPI in parts of Europe
Glenmark Pharmaceuticals announced that it has obtained semi-exclusive rights develop and market a generic fluticasone/salmeterol DPI in 15 European countries as part of an agreement with Polish pharmaceutical company Celon Pharma. The countries covered in the deal include the UK, Germany, Norway, Sweden, and Romania. Glenmark will pay an undisclosed amount up front, … [Read more...] about Glenmark makes deal with Celon to market fluticasone/salmeterol DPI in parts of Europe
Upcoming INTFG meeting will feature talk on nose-to-brain drug delivery
The business meeting of AAPS's Inhalation and Nasal Technology Focus Group (INTFG), which will take place on October 27 during the 2015 AAPS Annual Meeting in Orlando, FL, will include a talk by Next Breath Co-Founder and President Julie Suman. Suman will present an overview of "Nose to Brain Drug Delivery" that will include a discussion of the rationale for … [Read more...] about Upcoming INTFG meeting will feature talk on nose-to-brain drug delivery
Meda announces launch of Dymista nasal spray in Canada
Meda Pharmaceuticals in Canada has announced that Health Canada has approved Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of moderate-to-severe seasonal allergic rhinitis for patients age 12 years old and older who do not achieve sufficient symptom relief with either antihistamines or intranasal corticosteroids. According … [Read more...] about Meda announces launch of Dymista nasal spray in Canada
Foradil Aerolizer discontinued
The FDA has issued a drug shortage report for Foradil Aerolizer formoterol fumarate inhalation powder due to discontinuation of the product. According to the FDA website: "Novartis (manufacturer) and Merck have jointly decided to voluntarily discontinue manufacture of Foradil Aerolizer for business reasons. It is anticipated that inventory will be exhausted and no … [Read more...] about Foradil Aerolizer discontinued
GSK announces results from studies of Incruse Ellipta vs tiotropium and glycopyrronium
GlaxoSmithKline has announced data from two studies demonstrating that the Incruse Ellipta umeclidinium DPI produced statistically significant increase in FEV1 at 12 weeks in COPD patients compared to tiotropium and was non-inferior to glycopyrronium. GSK said that data from both 12-week randomized, blinded head-to-head studies will be presented at a future scientific … [Read more...] about GSK announces results from studies of Incruse Ellipta vs tiotropium and glycopyrronium
Similar hospital readmission rates for COPD patients using Brovana vs. fluticasone/salmeterol or tiotropium bromide
Sunovion is presenting data from retrospective database analyses in two separate posters at the 2015 American College of Chest Physicians annual meeting that show similar rates of hospital readmission for COPD patients treated with Brovana arformoterol tartrate inhalation solution compared to fluticasone/salmeterol or tiotropium bromide. Rates of 1-month all-cause … [Read more...] about Similar hospital readmission rates for COPD patients using Brovana vs. fluticasone/salmeterol or tiotropium bromide
Imprimis Pharmaceuticals acquires intranasal formulation compounding pharmacies
Imprimis Pharmaceuticals has announced the acquisition of what it says are the largest compounding pharmacies for sinus drugs in the US: Topical Apothecary Group, LLC (doing business as TAG Pharmacy), Aerosol Science Laboratories, Inc. (ASL Pharmacy), and SinuTopic, Inc. (Sinus Dynamics Pharmacy). Websites for all three are nearly identical, offering compounding of … [Read more...] about Imprimis Pharmaceuticals acquires intranasal formulation compounding pharmacies