Regulatory

The FDA has approved 40μg and 80μg strengths of Teva's QVAR RediHaler beclomethasone dipropionate breath-actuated MDI for treatment of asthma in patients aged 4 and older, the company said. Teva said that it expects to launch the product in the US in the first quarter of 2018. The current version of QVAR, which added a dose counter, was approved by the FDA in 2014. … [Read more...] about Teva’s QVAR RediHaler approved by the FDA

The FDA has designated the established name for Insmed's inhaled amikacin, which is in Phase 3 development for the treatment of nontuberculous mycobacteria (NTM) lung infections, as "amikacin liposome inhalation suspension," the company said in a business update. Insmed has previously called its amikacin suspension Arikayce and is now referring to the product as … [Read more...] about Insmed’s inhaled liposomal amikacin gets established name

According to Indivior, the French regulatory agency Agence nationale de sécurité du médicament et des produits de santé (ANSM) has approved the company's MAA for Nalscue naloxone hydrochloride nasal spray for the reversal of opioid overdose. Nalscue had been available in France under a Temporary Authorization for Use since July 2016. Indivior Chief Medical Officer … [Read more...] about Indivior’s Nalscue naloxone nasal spray approved in France

Aradigm Corporation has filed a new drug application to for Linhaliq inhaled ciprofloxacin (formerly Pulmaquin) for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE), the company said. The company said that the NDA is supported by positive data from the Phase 3 ORBIT-3 and ORBIT-4 studies. In 2014, … [Read more...] about Aradigm submits NDA for Linhaliq (formerly Pulmaquin) for non-cystic fibrosis bronchiectasis

GSK has filed a supplementary NDA for approval of a 50mcg once-daily dose of the Arnuity Ellipta fluticasone furoate DPI for the treatment of asthma in children aged 5-11. The FDA approved 100mcg and 200mcg doses of Arnuity Ellipta for the treatment of asthma in patients aged 12 and over in August 2014. According to GSK, the sNDA includes data from a 12-week … [Read more...] about GSK files sNDA for Arnuity Ellipta

Samumed's SM04646 inhaled Wnt pathway inhibitor has been granted orphan drug designation by the FDA, the company has announced. The company recently announced positive Phase 1 results for SM04646, which it is developing for the treatment of ideopathic pulmonary fibrosis. According to Samumed, SM04646 has the potential for use as either as a combination therapy … [Read more...] about Samumed’s inhaled Wnt pathway inhibitor gets orphan drug designation

GlaxoSmithKline and Innoviva have announced the filing of a submission to the EMA for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI (marketed as Breo Ellipta in the US) by patients whose asthma is adequately controlled with the use of an ICS/LABA combination. Relvar Ellipta was approved in the EU for the treatment of asthma not adequately … [Read more...] about GSK submits application to allow use of Relvar Ellipta for adequately controlled asthma

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the reclassification of Nasonex mometasone furoate nasal spray from a "POM," or "prescription only medicine," to a "P" medicine, available over the counter at pharmacies with pharmacist supervision. The product is approved for the treatment of allergic rhinitis. Bayer, which acquired … [Read more...] about MHRA reclassifies Nasonex nasal spray for other the counter sales in UK

Functional respiratory imaging (FRI) specialist Fluidda has requested a Critical Path Innovation Meeting (CPIM) with the FDA as part of an initiative for approval of its FRI technology as a biomarker, the company said. According to Fluidda CEO Jan de Backer, the company will use the CPIM to bring the FDA up to date on development and validation of FRI, which the … [Read more...] about Fluidda requests Critical Path Innovation Meeting with FDA as part of biomarker approval initiative

The FDA has accepted for review Sunovion's resubmission of the NDA for SUN-101/eFlow glycopyrrolate inhalation solution for the treatment of COPD, the company said. Sunovion received a complete response letter to the previously submitted NDA in May 2017. The PDUFA date for the resubmitted NDA is December 15, 2017. The original NDA was accepted for review in … [Read more...] about Sunovion has resubmitted the NDA for SUN-101/eFlow glycopyrrolate inhalation solution