Regulatory

GlaxoSmithKline and Innoviva have announced the submission of a supplemental New Drug Application for broader use of Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for COPD based on data from the IMPACT study. Trelegy Ellipta was initially approved by the FDA in September 2017 for COPD patients already using the Breo Ellipta fluticasone … [Read more...] about GSK files sNDA for Trelegy

According to Cipla, the company's ANDA for generic budesonide inhalation suspension has been approved by the FDA for the treatment of asthma in children aged 12 months to 8 years. Cipla will market the generic version of Pulmicort Respules in 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL strengths, with product available for shipping immediately. Read the Cipla press … [Read more...] about Cipla gets FDA approval for generic version of Pulmicort Respules

The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) met on November 16, 2017 to consider Bayer HealthCare's NDA for ciprofloxacin inhalation powder for the reduction of exacerbations in non-cystic fibrosis bronchiectasis patients who have bacterial lung infections. After discussion, the members of the committee voted against recommendation of approval for both of … [Read more...] about FDA advisory committee recommends against approval of Bayer’s ciprofloxacin DPI

The European Commission has approved GSK's marketing authorization application for Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD, the company said. The EMA Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion regarding the Trelegy Ellipta MAA in September 2017. According to GSK, the … [Read more...] about Trelegy Ellipta approved in Europe

Theravance Biopharma and Mylan have submitted an NDA to the FDA for revefenacin inhalation solution (TD-4208) for the treatment of COPD, the companies said. Theravance and Mylan announced their partnership on the development of nebulized TD-4208 in early 2015. In October 2016, the companies reported positive results from 2 Phase 3 efficacy studies, with positive … [Read more...] about Mylan and Theravance submit NDA for revefenacin inhlation solution

Novoclem Therapeutics says that its BIOC51 inhaled antimicrobial has received Qualified Infectious Disease Product (QIDP) designation from the FDA. The company says that BIOC51 could be delivered as either a dry powder or as an inhalation solution for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. According to Novoclem, "BIOC51 is a … [Read more...] about Novoclem gets QIDP designation for its inhaled antimicrobial BIOC51

The FDA has approved an updated nebulizer for use with United Therapeutics' Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension, the company said. The new TD-300/A device will be launched next year. According to United Therapeutics, the TD-300/A nebulizer "has a cleaner, more ergonomic design that includes single button … [Read more...] about FDA approves new device for use with Tyvaso inhalation solution

According to Mundipharma, the Flutiform fluticasone propionate/formoterol fumarate k-haler breath-activated MDI has received marketing approval through the European decentralized procedure for the treatment of asthma in patients 12 and older. The company had submitted the MAA in March 2016. Flutiform k-haler delivers the same dosages as the existing Flutiform MDI, … [Read more...] about Flutiform k-haler for the treatment of asthma gets European approval

Pulmatrix has announced that its PUR1900 itraconazole DPI has received Qualified Infectious Disease Product (QIDP) designation for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients. PUR1900 received Orphan Drug designation in 2016 and QIDP status in January 2017 for the treatment of ABPA in cystic fibrosis patients. In September … [Read more...] about Pulmatrix’s PUR1900 gets additional QIDP designation