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 delivered by GSK's Ellipta device. Earlier this year, GSK announced that it would file the submission by the end of 2016 … [Read more...] about GSK submits NDA for triple combination DPI for COPD

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 sensor for the Ellipta DPI in December 2015. GSK Head of Respiratory R&D Dave Allen commented, "While it is still in the early stages of development, the … [Read more...] about Propeller Health inhaler monitoring platform gets 510(k) clearance for use with the Ellipta DPI

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 The FDA published the draft guidance for fluticasone propionate/salmeterol xinafoate in September 2013. The Sandoz citizen petition, submitted October 13, 2016, contends that … [Read more...] about Sandoz files citizen petition challenging FDA Advair bioequivalence recommendations

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 adults. The vote was 17-1 on the question of whether at least one of the SER120 doses is effective and 14-4 on the question of whether the … [Read more...] about FDA committee recommends approval of Allergan’s SER120 desmopressin nasal spray

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