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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

Cipla said that it has received final approval for an ANDA for its generic version of Bausch’s Migranal dihydroergotamine (DHE) mesylate nasal spray for the treatment of migraine. According to Cipla, this is the company’s… Read more . . .