Regulatory

An FDA warning letter to Cipla dated November 17, 2023 cites numerous problems found in a February 2023 inspection of Cipla's metered dose inhaler manufacturing facility in Pithampur, Madhya Pradesh, India. Among the issues cited in the letter is a failure to respond adequately to more than 3,000 complaints received between April 2020 and December 2022 that reported … [Read more...] about FDA issues warning letter to Cipla citing significant problems at inhaler manufacturing facility, including continued production of defective MDIs

Orexo said that the FDA has accepted the company's NDA for OX124 intranasal dry powder high dose naloxone for the reversal of opioid overdose and has set a PDUFA date of July 15, 2024. The company initially announced that it had submitted an NDA for OX124 in February 2023; however, the FDA rejected that application, requesting additional information about the … [Read more...] about FDA accepts Orexo’s NDA for OX124 intranasal dry powder naloxone for the treatment of opioid overdose

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

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

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

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 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