Regulatory

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

The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 12 to 2 in favor of approval for Forest Laboratories' and Almirall's NDA for a 400 μg twice daily dose aclidinium bromide inhalation powder to treat COPD. Although the briefing materials for the advisory committee meeting raised questions about the safety of inhaled long-acting muscarinic agents … [Read more...] about FDA advisory committee recommends approval of aclidinium bromide inhalation powder

Among the warning letters posted to the FDA website on February 21, 2012 is a letter to FSC Laboratories dated June 9, 2011 detailing violations related to quality controls for the manufacture of the E-Z Spacer collapsible holding chamber for metered dose inhalers. According to the letter, a March 2011 FDA inspection found that the company "is a virtual company that … [Read more...] about FDA posts 2011 warning letter to MDI spacer marketer

The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) will meet on Thursday, February 23 to decide whether or not to approve Forest Labs' aclidinium bromide inhalation powder for the treatment of COPD. Forest submitted an NDA for the product in June 2011. In its briefing package for the advisory committee members, the FDA cites known cardiac safety issues … [Read more...] about FDA expresses concerns about aclidinium safety ahead of advisory committee meeting

According to the Associated Press, the FDA will investigate the safety of Aeroshot inhalable caffeine and whether the product can be considered a dietary supplement as the manufacturer claims or if it is subject to regulation as a drug. AeroShot is manufactured by Breathable Foods, co-founded by Harvard professor David Edwards. The report says that FDA Commissioner … [Read more...] about FDA to review inhaled caffeine product

Alexza Pharmaceuticals says that the Day 80 Assessment Report it has received from the European Medicines Agency (EMA) regarding its Marketing Authorization Application (MAA) for Adasuve Staccato loxapine indicates that the report "outlines major objections pertaining to the extrapolation of the Phase 3 study population to the intended patient population, pulmonary … [Read more...] about EMA outlines objections to Adasuve MAA in Day 80 assessment report