Regulatory

Evoke Pharma says that it recently had a positive pre-NDA meeting with the FDA regarding clinical data to be included in its planned 505(b)(2) NDA for Gimoti intranasal metoclopramide for the treatment of diabetic gastroparesis… Read more . . .

GlaxoSmithKline and Innoviva have announced that GSK has filed an MAA with the European Medicines Agency for its fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD. In November 2016, GSK submitted an NDA for the… Read more . . .

GlaxoSmithKline and Innoviva have announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the 100/25 mcg strength of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of COPD. Both the… Read more . . .

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 The FDA published the draft guidance for… Read more .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 . . .