Regulatory

According to Avanir Pharmaceuticals,the FDA has issued a Discipline Review letter in response to the company’s NDA for AVP-825 intranasal dry powder sumatriptan requesting that the company “optimize the product-user interface” and conduct additional human… Read more . . .

Accordig to Sandoz, the company has received marketing authorization in Estonia, Latvia and Lithuania for the 50-250 and 50-500 µg dosages of the AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD. The… Read more . . .

The Portuguese Health Authority (Infarmed) has approved Sandoz’s AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD, triggering a €1.5 million milestone payment to developer Vectura. Sandoz licensed AirFluSal Forspiro from Vectura in… Read more . . .

Almirall has announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the company’s aclidinium bromide/formoterol fumarate DPI for the treatment of COPD. Almirall will market the product as… Read more . . .

According to Boehringer Ingelheim, the FDA has approved the company’s Spiriva Respimat tiotropium bromide inhalation soft mist inhaler for the treatment of COPD. In August 2014, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted in… Read more . . .

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 . . .