Regulatory

GlaxoSmithKline has submitted an NDA in the US for its fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) dry powder inhaler for the treatment of COPD, according to an announcement from GSK and Innoviva. The product will be… Read more . . .

Propeller Health has announced that its inhaler monitoring platform has received 510(k) clearance from the FDA for use with the Ellipta dry powder inhaler. The company had announced a deal with GSK to develop a… Read more . . .

Fierce Pharma has published a copy of a citizen petition filed by Sandoz that challenges the FDA’s recommendations for establishing bioequivalence for generic copies of Advair Diskus 100/50. The FDA published the draft guidance for… Read more . . .

The FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) has voted to recommend approval of Allergan’s SER120 desmopressin nasal spray for the treatment of nocturia (needing to wake up to urinate at night) in… Read more . . .

The FDA’s October 2016 release of new bioequivalence recommendations for specific products includes draft BE guidances for umeclidinium bromide inhalation powder (Incruse Ellipta), triamcinolone acetonide nasal spray (Nasacort), and olopatadine hydrochloride nasal spray (Patanase). For… Read more . . .

The FDA has accepted Sunovion’s NDA for SUN-101 glycopyrrolate delivered by the PARI eFlow nebulizer for the treatment of COPD, the company said. The agency has set a PDUFA date of May 29, 2017 for… Read more . . .

Chiesi Farmaceutici has submitted an MAA to the European Medicines Agency (EMA) for its extra-fine ICS/LABA/LAMA combination inhaler for the treatment of COPD. The submission is the first for a triple combination inhaler. In June… Read more . . .

Health Canada has approved Adapt Pharma’s Narcan naloxone nasal spray for reversal of known or suspected opioid overdose. The approval comes three months after Health Canada announced that it would allow importation of Narcan nasal… Read more . . .

According to Windtree Therapeutics, its Aerosurf inhaled lucinactant for the treatment of premature infants with respiratory distress syndrome (RDS) has received Fast Track designation from the FDA. Aerosurf is currently in Phase 2 development, with… Read more . . .

According to Evoke Pharma, the company held a pre‑NDA meeting with the FDA about its intranasal metocopramide for the treatment of diabetic gastroparesis in adult women and now believes that it will be able to… Read more . . .