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 equivalents to Incruse Ellipta, in addition to recommendations for in vitro, … [Read more...] about FDA issues bioequivalence guidances for umeclidinium bromide, triamcinolone acetonide, olopatadine hydrochloride

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 completion of its review of the application. In April 2016, Sunovion announced that the GOLDEN-3 and GOLDEN-4 trials of SUN-101 had met their primary endpoints and said … [Read more...] about FDA accepts Sunovion’s NDA for SUN-101 glycopyrrolate inhalation solution

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 2016, Chiesi reported positive Phase 3 results for its beclamethasone/formoterol/glycopyrronium MDI, saying that it planned to submit an … [Read more...] about Chiesi submits MAA for triple combination inhaler

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 spray from the US, an order than remains in effect. Adapt says that it is working out distribution arrangements and will announce … [Read more...] about Health Canada approves Narcan nasal spray

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 a Phase 2b clinical trial in premature infants receiving nasal continuous positive airway pressure (nCPAP) RDS … [Read more...] about Windtree’s Aerosurf gets FDA Fast Track designation

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 complete the CMC and non-clinical sections of its 505(b)(2) NDA in a manner that will be acceptable to the agency. Evoke recently announced that a Phase 3 … [Read more...] about Evoke Pharma moving forward with NDA for intranasal metoclopramide

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 patients 18 years old and over beginning in early 2017. GSK President of Consumer Healthcare North America Colin … [Read more...] about Flonase Allergy Relief approved for OTC sales in Canada

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 and single doses of 40 mg for anyone older than 10. Inavir was approved in Japan for the treatment of influenza A and B in 2010 and for the prevention of … [Read more...] about Japanese regulators approve additional dosage regimen for the Inavir DPI

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 on a plausible hypothesis that your drug may be clinically superior to the same drug that is already approved for the same indication." The … [Read more...] about Pulmatrix’s PUR1900 itraconazole DPI gets orphan drug designation

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 as a treatment for major depressive disorder with an imminent risk of suicide, and 6 clinical trials are currently … [Read more...] about Janssen’s intranasal esketamine gets Breakthrough Therapy Designation