Regulatory

According to Boehringer Ingelheim, the FDA has approved its tiotropium bromide/olodaterol soft mist inhaler for the treatment of COPD. The company filed an NDA for the product, which will be marketed as Stiolto Respimat Inhalation Spray, in August 2014. New data analyses from Phase 3 studies showing improved lung function for patients using the combination … [Read more...] about FDA approves Stiolto Respimat for the treatment of COPD

Advanced Inhalation Therapies (AIT) has announced that its AIT-CF high dose inhaled formulation of nitric oxide (NO) for the treatment of cystic fibrosis has been granted orphan medical product designation by the European Commission. In February 2015, the company announced that the product had received orphan drug designation from the FDA in late 2014. AIT Chief … [Read more...] about AIT’s nitric oxide product for CF gets European orphan designation

The FDA has approved GSK's supplemental NDA for the Breo Ellipta fluticasone furoate/vilanterol DPI, allowing GSK to market the inhaler for the treatment of asthma in patients aged 18 years and older. Breo Ellipta was approved by the FDA for the treatment of COPD in May 2013. In March 2015, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug … [Read more...] about FDA approves Breo Ellipta for the treatment of asthma in adults

PARI Pharma has received European marketing authorization for its Vantobra 170 mg tobramycin/1.7 ml inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients aged 6 and older, the company said. Vantobra is delivered via the Tolero nebulizer and is packaged together with the device. PARI Pharma submitted the marketing authorization … [Read more...] about PARI Pharma’s Vantobra inhalation solution approved in Europe

Kyorin Pharmaceutical has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its marketing application for the Eklira Genuair aclidinium bromide DPI for the treatment of COPD in 30 and 60 inhalation versions. Kyorin licensed Eklira Genuair from Almirall in February 2011. The company also markets SkyePharma's Flutiform … [Read more...] about Eklira Genuair approved in Japan

The FDA has now approved Teva's ProAir RespiClick albuterol DPI for the treatment of asthma in patients aged 12 and older, the company said. Teva had announced tentative approval of the product, which was previously known as ProAir Spiromax, on March 5, 2015. Teva Senior VP, Global Respiratory R&D, Tushar Shah commented, "Teva is committed to optimizing … [Read more...] about ProAir RespiClick gets FDA approval

According to GSK, the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved its Encruse Ellipta umeclidinium DPI for the treatment of COPD, and the company plans to launch the product in Japan sometime this year. The approved dosage is 62.5 mcg. GSK announced in May 2014 that it had filed the application for the inhaler, which is approved in the US … [Read more...] about Encruse Ellipta approved in Japan

According to Invion Limited, the company "has received a positive response" from the FDA during a pre-IND meeting regarding its INV102 inhaled nadolol for the treatment of asthma and COPD. Invion is developing the drug in partnership with 3M Drug Delivery Systems, and the company said that the agency has accepted both the formulation and proprietary MDI technology … [Read more...] about Invion announces successful pre-IND meeting with FDA for inhaled nadolol