Regulatory

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 . . .

GlaxoSmithKline Consumer Healthcare has announced the approval of Flonase Allergy Relief fluticasone propionate nasal spray for the treatment of allergic rhinitis for over-the-counter (OTC) sales in Canada. The nasal spray will be available OTC for… Read more . . .

Daiichi Sankyo has announced that Japanese regulators have approved the use of its Inavir laninamivir octanoate hydrate DPI for the prevention of influenza in single doses of 20 mg for children under 10 years old… Read more . . .

According to Pulmatrix, the FDA has granted orphan drug status to the company’s PUR1900 itraconazole DPI for the treatment of fungal lung infections in cystic fibrosis patients, with the FDA stating, “Your designation is based… Read more . . .

Johnson & Johnson has announced that intransal esketamine being developed by its subsidiary Janssen Research & Development has received Breakthrough Therapy Designation from the FDA. According to J&J, the product is in Phase 3 development… Read more . . .