Regulatory

The British Pharmacopoeial Commission is requesting comment from OINDP manufacturers regarding proposed changes to its inhaled product monographs. The BP has posted a draft document authored by its Inhaled Products Working Party and has asked that manufacturers of MDIs, DPIs, and nebulizer solutions submit comments along with any relevant data. The draft document … [Read more...] about British Pharmacopoeial Commission requests comment on changes to inhaled product monographs

The FDA has issued a complete response letter to MAP Pharmaceuticals' NDA for Levadex dihydroergotamine inhalation aerosol for the treatment of migraine headaches. According to MAP, "the FDA requested that the Company address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. … [Read more...] about MAP gets complete response letter for Levadex inhaled dihydroergotamine

According to Teva, the FDA has approved its QNASL HFA beclomethasone dipropionate nasal aerosol for the treatment of seasonal and perennial allergic rhinitis in adults and children 12 years of age and older, and the company plans to launch the product by the end of April 2012. QNASL is delivered by a pressurized nasal delivery device that includes a dose counter. Teva … [Read more...] about FDA approves QNASL HFA nasal aerosol

Meda has announced that its Astepro azelastine nasal spray for the treatment of allergic rhinitis has received registration approval in Europe through the centralized procedure and that it will now begin the national registration processes in individual countries in anticipation of a 2013 launch. Earlier this year, Meda filed suit against Apotex and Perrigo in the US … [Read more...] about Astepro nasal spray approved in Europe

The FDA has cleared Aradigm's Investigational New Drug Application (IND) for a Phase 3 clinical trial of Pulmaquin dual release ciprofloxacin for inhalation in non-cystic fibrosis bronchiectasis. The Phase 3 program include two one-year placebo-controlled trials with 250 patients each. The company announced plans for the trials in December, 2011. Aradigm President … [Read more...] about Aradigm gets FDA clearance for Phase 3 trial of Pulmaquin

The FDA has approved Teva's ProAir HFA albuterol metered dose inhaler with a dose counter for the treatment and prevention of bronchospasm in patients 4 years of age and older. According to the company, the new product will be available by the end of 2012. Teva Global Respiratory Research and Development Senior VP Tushar Shah explained: “The dose counter is … [Read more...] about Teva’s ProAir HFA MDI with dose counter approved by FDA

The FDA has issued a warning letter to Breathable Foods, the manufacturer of AeroShot inhalable caffeine for "false or misleading statements in the labeling of their product." The agency is also questioning the safety of the inhaler, including the possibility that users may inhale the formulation into their lungs, that children will use the product, and that AeroShot … [Read more...] about FDA issues warning letter on inhalable caffeine

The FDA has approved MedImmune's FluMist Quadrivalent for the prevention of influenza, making the intranasal vaccine the first approved quadrivalent flu vaccine in the US. FluMist Quadrivalent contains two type A strains and type B strains from both B/Yamagata and B/Victoria. All other currently approved seasonal flu vaccines are trivalent. University of Kentucky … [Read more...] about FluMist Quadrivalent intranasal vaccine gets FDA approval

Forest Laboratories has received EMA approval to market Colobreathe dry powder colistimethate sodium inhalation powder for the treatment of P. aeruginosa infections in cystic fibrosis patients aged 6 years and older, according to the company. The company already markets a colistimethate sodium inhalation solution for nebulization under the brand name Colomycin in the … [Read more...] about European marketing approval for Forest’s Colobreathe dry powder inhaler