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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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.… Read more . . .

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… Read more . . .

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… Read more . . .