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 drug which, according to the company, breaks down mucus and prevents formation of biofilms in the lungs of CF patients. A Phase 2a … [Read more...] about NovaBiotics’ Lynovex for CF gets US orphan drug designation

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 prevent craving and nicotine withdrawal symptoms associated with tobacco dependence." Kind Consumer Chief Medical Officer Chris Moyses … [Read more...] about Voke nicotine inhaler approved in the UK

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 3 trial of Pulmaquin for that indication in June 2014. The product received Qualified Infection Disease … [Read more...] about Aradigm gets fast track designation for Pulmaquin

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 and another FP inhaler, PSX1050, in most of Europe, North America, Japan, Australia, India, and a number of other countries. PSX1050 … [Read more...] about Prosonix submits MAA for generic fluticasone propionate MDI

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 web site is a single page that says "PulmoFlow is a newly established company currently focused on solutions to improve the lives of patients … [Read more...] about Tobramycin inhalation solution gets tentative FDA approval

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 µg, 50-250 µg and 50-500 µg. The product will be marketed as IrFlosol Forspiro in Mexico. The Mexican approval … [Read more...] about Airflusal Forspiro approved in Mexico

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 for patients age 12 and older. GSK submitted the NDA for Arnuity Ellipta in October 2013. GSK Senior VP and Head, GSK Global Respiratory … [Read more...] about FDA approves GSK’s fluticasone furoate DPI, Arnuity Ellipta

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 at the end of July 2014, and the agency's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recently voted in favor of … [Read more...] about Boehringer Ingelheim files NDA for tiotropium/olodaterol Respimat

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 2007. Numerous safety questions about tiotropium have been raised over the years, and a briefing document for the PADAC … [Read more...] about FDA advisory committee votes for approval of Spiriva Respimat