Regulatory

Sunovion has submitted a new drug application to the FDA for its SUN-101/eFlow glycopyrrolate for the treatment of COPD, the company said. The company recently reported positive results from the GOLDEN-5 long-term safety study of SUN-101/eFlow and had previously reported data from the GOLDEN-3 and GOLDEN-4 efficacy trials that are being used to support the NDA. … [Read more...] about Sunovion submits NDA for SUN-101/eFlow glycopyrrolate for COPD

The FDA has approved St. Renatus's Kovanaze tetracaine HCl and oxymetazoline HCl nasal spray, the company announced. The product is approved for regional anesthesia for adults and children weighing 40 kg or more who are having work done on the upper incisors, canines, or premolars. The company announced positive results from a Phase 3 study of the nasal spray in … [Read more...] about FDA approves nasal spray dental anesthetic

While Health Canada conducts an expedited review of a new drug submission (NDS) for naloxone nasal spray, Minister of Health Jane Philpott has signed an Interim Order temporarily allowing naloxone nasal spray imported from the US to be sold in Canada. Currently, the only form of naloxone available in Canada is injectable. Adapt Pharma submitted the NDS to Health … [Read more...] about Health Canada allows temporary importation of naloxone nasal spray from the US

The FDA has made the approval packages for Boehringer Ingelheim's Stiolto Respimat and Spiriva Respimat available on its website. The Stiolto Respimat tiotropium bromide/olodaterol SMI, which is marketed as Spiolto Respimat in Europe, was approved for the treatment of COPD by the FDA in May 2015. Spiriva Respimat tiotropium bromide SMI was approved for the treatment … [Read more...] about Approval packages for Stiolto Respimat and Spiriva Respimat now available

Teva has announced the FDA's acceptance of the company’s NDAs for fluticasone propionate (FP)/salmeterol and FP monotherapy DPIs for the treatment of asthma. Both products are delivered using the breath-activated RespiClick inhaler. In late 2015, Teva announced positive data from Phase 3 studies of both products. The FDA is expected to take action on both … [Read more...] about FDA accepts Teva NDAs for fluticasone propionate/salmeterol and FP monotherapy DPIs

The Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) has recommended against the use of MedImmune's FluMist Quadrivalent Live Attenuated Influenza Vaccine (FluMist Quadrivalent) for the 2016-2017 influenza season because the intranasal vaccine has failed to demonstrate significant effectiveness in children … [Read more...] about US Centers for Disease Control (CDC) advises against using FluMist for 2016-17

Insmed has announced the withdrawal of its marketing authorization application for Arikayce inhaled liposomal amikacin for the treatment of nontuberculous mycobacteria (NTM) lung disease. The MAA was submitted to the European Medicines Agency in 2014, prior to the beginning of a Phase 3 study. According to the company, the Committee for Medicinal Products for … [Read more...] about Insmed withdraws MAA for Arikayce for nontuberculous mycobacteria (NTM)

GlaxoSmithKline plc (LSE:GSK) and Innoviva have announced that the planned submission of an NDA for a triple therapy DPI for the treatment of COPD has been moved up from the first half of 2018 to the end of 2016, following discussions with the FDA. The fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) combination is delivered using the Ellipta inhaler. The … [Read more...] about GSK to file NDA for FF/UMEC/VI combination by the end of 2016