Regulatory

According to Aradigm Corporation, the FDA has accepted its NDA for Linhaliq dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients for priority review. The agency set a PDUFA date of January 26, 2018. Aradigm announced its submission of the NDA in July 2017. Linhaliq … [Read more...] about Aradigm’s NDA for Linhaliq gets priority review status from FDA

GlaxoSmithKline announced that its NDA for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol for the treatment of COPD has been approved by the FDA. GSK said that Trelegy Ellipta should be available to patients in the US "shortly." The FDA approval comes days after the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion … [Read more...] about Trelegy Ellipta approved by the FDA

The FDA has approved Optinose's Xhance fluticasone propionate nasal spray (formerly OPN-375) for the treatment of nasal polyps, the company said. The product, which is based on the company's exhalation delivery technology, should be available in the US by mid-2018. In January 2017, OptiNose announced that the FDA had accepted its NDA for OPN-375. The company had … [Read more...] about Optinose’s Xhance fluticasone propionate nasal spray gets FDA approval

The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Mundipharma's MAA for Nyxoid naloxone nasal spray for the reversal of opioid overdose. Currently, no intranasal naloxone formulations are approved for use across the entire EU. Indivior's Nalscue nasal spray was approved in France in July 2017. Adapt Pharma submitted an MAA … [Read more...] about Mundipharma’s Nyxoid naloxone nasal spray gets positive opinion from CHMP

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding GSK's MAA for its triple combination fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD in patients whose symptoms are not adequately controlled by an ICS/LABA combination. GSK plans to market the product in Europe … [Read more...] about CHMP issues positive opinion regarding GSK’s Trelegy Ellipta triple combination DPI

The FDA has approved a supplemental NDA for AstraZeneca's Symbicort budesonide/formoterol fumarate MDI extending its use to include the reduction of COPD exacerbations. The sNDA, which was approved on September 11, 2017, included supporting data from two Phase 3b studies according to AstraZeneca. In August 2016, AstraZeneca announced positive results from the … [Read more...] about Symbicort approved for reduction of COPD exacerbations

Summit Biosciences has announced that it can now produce prescription nasal sprays for the the European market after receiving EU GMP certification from the Medicines and Healthcare Products Regulatory Agency (MHRA) for its manufacturing facilities in Lexington, Kentucky. According to the company, Summit sought the certification "in anticipation of the European … [Read more...] about Nasal spray manufacturer Summit Biosciences gets GMP certificate from MHRA

Acorda Therapeutics has received a refusal to file letter from the FDA in response to its NDA for Inbrija (CVT-301) inhaled levodopa for the treatment of OFF periods in Parkinson’s disease patients, the company said. Acorda submitted the 505(b)(2) NDA in June 2017. According to the company, the FDA letter said that the NDA lacked sufficient information for review, … [Read more...] about Acorda gets refusal to file letter for Inbrija inhaled L-dopa NDA