Regulatory

The EMA’s Committee for Medicinal Products for Human Use (“CHMP”) has issued a positive opinion on SkyePharma’s MAA for its flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of asthma. The MAA had been referred… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .