Regulatory

NovaBiotics has announced that its Lynovex (NM001) cysteamine for the treatment of cystic fibrosis has been granted orphan drug designation by the FDA. NovaBiotics is developing both oral and dry powder inhalation formulations of the… Read more . . .

According to Kind Consumer, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the company’s Voke nicotine inhaler for general sale. The company said that the license is “for use to relieve and/or… Read more . . .

The FDA has granted fast track designation to Aradigm’s Pulmaquin dual release inhaled ciprofloxacin for treatment of chronic Pseudomonas aeruginosa lung infections in non-cystic fibrosis bronchiectasis patients, the company said. Aradigm initiated a second Phase… Read more . . .

Prosonix has submitted an MAA for its PSX1001 fluticasone propionate MDI for the treatment of asthma, triggering a milestone payment from Mylan, the company has announced. In April 2014, Mylan acquired marketing rights for PSX1001… Read more . . .

According to the FDA, the agency has issued a tentative approval of an application by PulmoFlow, Inc. to market tobramycin 300 mg/5 ml inhalation solution. PulmoFlow, Inc. was established in Virginia in 2013. The company’s… Read more . . .

Sandoz has announced that the Mexican health authority, COFEPRIS, has approved the company’s marketing application for the Airflusal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and for COPD. Three dosage levels were approved: 50-100… Read more . . .

GlaxoSmithKline has announced that it has received FDA approval for its fluticasone furoate DPI, to be marketed as Arnuity Ellipta, for the maintenance treatment of asthma. The approval is for 100mcg and 200mcg doses and… Read more . . .

The FDA has accepted Boehringer Ingelheim’s New Drug Application for its tiotropium/olodaterol Respimat soft mist inhaler for the treatment of COPD, the company has announced. BI’s Striverdi Respimat olodaterol SMI was approved by the FDA… Read more . . .

The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 10-3 to approve Boehringer Ingelheim’s Spiriva Respimat tiotropium soft mist inhaler for the treatment of COPD. BI’s first NDA submission for tiotropium Respimat took place in… Read more . . .