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 factor testing. AVP-825 is delivered using OptiNose's Breath Powdered intranasal delivery device. Although the … [Read more...] about Avanir says NDA for AVP-825 unlikely to be approved by PDUFA date

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 inhaler is now approved in 13 European countries, as well as in Mexico and South Korea. Sandoz Head of Global Respiratory Jan-Torsten … [Read more...] about AirFluSal Forspiro approved in three more countries

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 2006. The Portuguese approval covers the 50-250 and 50-500 µg dosage forms. AirFluSal Forspiro is now … [Read more...] about Portugal approves AirFluSal Forspiro

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 Duaklir Genuair and Brimica Genuair in Europe. Almirall Chief Scientific Officer Thomas Eichholtz said, "We are very pleased … [Read more...] about CHMP recommends approval of Duaklir Genuair inhaler

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 favor of approval of the SMI. The company said that Spiriva Respimat should be available in January 2015. BI … [Read more...] about FDA approval for Spiriva Respimat

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