Regulatory

The Japanese Ministry of Health, Labour and Welfare has approved two Novartis DPIs -- Enerzair Breezhaler glycopyrronium / indacaterol/ mometasone furoate and Atectura indacaterol / mometasone furoate -- for the treatment of asthma, the company said. The two DPIs were part of a batch of five Novartis drugs approved simultaneously by the MHLW. Sosei Heptares, which … [Read more...] about Enerzair and Atectura Breezhalers approved in Japan

Over a dozen well-known OINDP specialists have issued a call for accelerated development of inhaled therapies for COVID-19, with the goal of getting these products to patients faster. Writing to the editor of the Journal of Aerosol Medicine and Pulmonary Drug Delivery, members of the Regulatory and Standardization Issues Networking Group of the International Society … [Read more...] about ISAM calls on pharmaceutical industry and regulators to prioritize development of inhaled therapies for COVID-19

The FDA has approved Evoke Pharma's Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis, the company said. Evoke originally submitted an NDA for Gimoti in in June 2018 and acknowledged receipt of a complete response letter to that NDA in April 2019. The company resubmitted the NDA in December 2019. In January 2020, Evoke announced that it … [Read more...] about Gimoti metoclopramide nasal spray approved by the FDA

DPI developer TFF Pharmaceuticals said that the FDA has granted orphan drug designation to its dry powder tacrolimus for the prevention of lung transplant rejection. The company also said that it plans to initiate a Phase 1 SAD study of the tracrolimus inhalation powder this month followed by a MAD study in the third quarter of this year. TFF President and CEO … [Read more...] about TFF gets orphan drug designation for inhaled tacrolimus for prevention of lung transplant rejection

The FDA has issued new and revised product-specific guidances (PSGs) for a number of OINDPs as of June 3, 2020. The agency also updated its list of planned PSGs for complex generics, adding a number of PSGs for OINDPs to that list. New PSGs issued on June 3 include: Glycopyrrolate/indacaterol maleate inhalation powderRevefenacin inhalation solution Revised … [Read more...] about FDA issues additional product-specific guidances for OINDPs

Microbion Corporation said that its pravibismane inhalation suspension for the treatment of lung infections in patients with cystic fibrosis has been granted orphan drug designation by the FDA. Pravibismane inhalation suspension has already been granted Fast Track and Qualified Infectious Disease Product (QIDP) designations for that indication. According to the … [Read more...] about Microbion gets orphan designation for pravibismane inhalation suspension for lung infections in CF patients