Regulatory

Acorda Therapeutics said that it has resubmitted an NDA for its Inbrija levodopa DPI for the treatment of OFF periods in Parkinson's disease patients. The company originally submitted the 505(b)(2) application in June 2017, and the FDA issued a refuse to file letter in response in August 2017. According to Acorda, the resubmitted application addresses two issues … [Read more...] about Acorda resubmits NDA for Inbrija L-Dopa DPI

Sunovion's NDA for Lonhala Magnair glycopyrrolate inhalation solution (formerly known as SUN-101/eFlow) has been approved by the FDA for the treatment of COPD, the company said. A US launch is planned in early 2018. In April 2016, Sunovion announced that the Phase 3 GOLDEN-3 and GOLDEN-4 studies had met their primary endpoints. The company's initial NDA for the … [Read more...] about Lonhala Magnair glycopyrrolate inhalation solution (formerly SUN-101/eFlow) approved by the FDA

Glenmark Pharmaceuticals Europe said that its marketing authorization application for a generic version of Seretide Accuhaler (Advair Diskus) for the treatment of asthma and COPD has been approved through the decentralized procedure in the Nordic region, making the fluticasone/salmeterol DPI the company's first inhaled product approved by European authorities. In … [Read more...] about Glenmark’s generic fluticasone/salmeterol DPI approved in Nordic countries

Aradigm has announced that the FDA's Antimicrobial Drugs Advisory Committee (AMDAC) will meet on January 11, 2018 to review the NDA for Linhaliq inhaled ciprofloxacin for the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients. Linhaliq is a mix of liposome-encapsulated and unencapsulated ciprofloxacin. The company submitted … [Read more...] about FDA advisory committee schedules review of Linhaliq NDA

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