Lupin announced that the Drug Controller General of India approved the company's Vilfuro-G vilanterol / fluticasone furoate / glycopyrronium bromide dry powder inhaler for the treatment of COPD, and the company has launched the DPI in India. Earlier this year, Lupin announced the launch of its Difizma indacaterol / glycopyrronium / mometasone DPI in India for the … [Read more...] about Lupin launches Vilfuro-G triple combination DPI in India
Regulatory
FTC challenges the listing of dozens of inhaler device patents in the Orange Book
The United States Federal Trade Commission (FTC) announced that it has challenged the Orange Book listings of more than 100 patents related to combination products, with most of those patents related to inhaler device components such as dose counters. According to warning letters that the FTC sent to sponsors of the NDAs affected by challenges, the inhalers involved … [Read more...] about FTC challenges the listing of dozens of inhaler device patents in the Orange Book
Biopas submits marketing applications for Inbrija levodopa DPI in six Central and South American countries
According to Acorda Therapeutics, Biopas Laboratories has submitted marketing applications for Inbrija levodopa inhalation powder for the treatment of OFF episodes in Parkinson's disease in Argentina, Colombia, Costa Rica, Ecuador, Panama, and Peru. In May 2022, Biopas acquired the rights to Inbrija in those 6 countries, plus Brazil, Chile, and Mexico. Acorda says … [Read more...] about Biopas submits marketing applications for Inbrija levodopa DPI in six Central and South American countries
SyqeAir cannabis inhaler gets TGA approval
According to Syqe Medical, Australia's Therapeutic Goods Administration (TGA) has approved the company's SyqeAir cannabis inhaler, which includes 60 metered doses of milled cannabis flowers. The cartridge-based inhaler will now appear in the Australian Register of Therapeutic Goods (ARTG). Novachem sponsored the application and will distribute SyqeAir in Australia. … [Read more...] about SyqeAir cannabis inhaler gets TGA approval
FDA accepts AstraZeneca’s sBLA for self-administration of FluMist Quadrivalent intranasal flu vaccine
According to AstraZeneca, the FDA has accepted for review the company's supplemental biologics license application (sBLA) for self-administration of FluMist Quadrivalent nasal spray vaccine against influenza. AstraZeneca says that it expects a PDUFA date in the first quarter of 2024, which would allow for self administration of FluMist for the 2024-25 flu season if … [Read more...] about FDA accepts AstraZeneca’s sBLA for self-administration of FluMist Quadrivalent intranasal flu vaccine
Milestone submits NDA for etripamil nasal spray for the treatment of PVST
Milestone Pharmaceuticals said that it has submitted an NDA for its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and that the FDA has conditionally approved the proposed trade name "Cardamyst." The company said that it is continuing preparations for an anticipated commercial launch. According to Milestone, the clinical … [Read more...] about Milestone submits NDA for etripamil nasal spray for the treatment of PVST
FDA okays home dosing of Tiziana’s intranasal foralumab for MS patients in expanded access program
According to Tiziana Life Sciences, the FDA is allowing patients with multiple sclerosis who are taking part in an expanded access program through Brigham and Women's Hospital to use intranasal foralumab at home instead of at the hospital. In April 2022, the company announced that the agency had agreed to allow the access program to expand to a total of 10 patients … [Read more...] about FDA okays home dosing of Tiziana’s intranasal foralumab for MS patients in expanded access program
Aculys says it will file NDA based on interim analysis of Japanese Phase 3 trial of NRL-1 (Valtoco) diazepam nasal spray
Aculys Pharma says that it plans to move ahead with submission of a marketing application to Japanese authorities based on interim data showing that a Japanese Phase 3 clinical study of NRL-1 diazepam nasal spray in epilepsy patients aged 6 to 17 met its primary efficacy endpoint. Aculys acquired development and commercialization rights to Neurelis's NRL-1 diazepam … [Read more...] about Aculys says it will file NDA based on interim analysis of Japanese Phase 3 trial of NRL-1 (Valtoco) diazepam nasal spray
FDA places clinical hold on GH Research IND for GH001 inhaled 5-MeO-DMTFDA
GH Research announced that the FDA has placed a clinical hold on an IND that the company submitted for GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression, citing "Insufficient information to assess risks to human subjects." The company said that it is waiting to learn more details from the FDA about the reasons for the clinical … [Read more...] about FDA places clinical hold on GH Research IND for GH001 inhaled 5-MeO-DMTFDA
FDA accepts Defender’s NDA for DPI-386 scopolamine nasal gel for priority review
According to Defender Pharmaceuticals, the FDA has accepted the company’s NDA for DPI-386 scopolamine nasal gel for the treatment of motion sickness for priority review, with a PDUFA goal date of January 26, 2024. Defender submitted the NDA in July 2023. The company said that the FDA granted priority review at the request of the US Navy. Defender President and CEO … [Read more...] about FDA accepts Defender’s NDA for DPI-386 scopolamine nasal gel for priority review