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Regulatory

Firebrick no longer seeking approval of Nasodine nasal spray in Australia

Firebrick Pharmaceuticals announced that it has withdrawn its appeal of a decision by the Therapeutic Goods Administration (TGA), which refused to approve the company's Nasodine povidone-iodine nasal spray as a treatment for the common cold. Firebrick said that the withdrawal was due to "the significant distraction and legal costs associated with proceeding," … [Read more...] about Firebrick no longer seeking approval of Nasodine nasal spray in Australia

FDA issues Refuse to File letter in response to Milestone’s NDA for etripamil nasal spray

According to Milestone Pharmaceuticals, the FDA has refused to file the company's NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and has "requested clarification about the time of data recorded for adverse events" during Phase 3 trials. Milestone submitted the NDA in October 2023. Milestone initiated the Phase 3 … [Read more...] about FDA issues Refuse to File letter in response to Milestone’s NDA for etripamil nasal spray

Court upholds PTAB ruling invalidating United Therapeutics’ patent at center of suit delaying final approval Liquidia’s Yutrepia treprostinil DPI

According to Liquidia Corporation, the company will immediately take steps toward getting final FDA approval of Yutrepia treprostinil DPI now that the US Court of Appeals has upheld a decision by the Patent Trial and Appeal Board (PTAB) invalidating all of the claims of US Patent No. 10,716,793. Earlier this year, the Court of Appeals upheld a District Court ruling … [Read more...] about Court upholds PTAB ruling invalidating United Therapeutics’ patent at center of suit delaying final approval Liquidia’s Yutrepia treprostinil DPI

FDA extends review period for Optinose’s sNDA for Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis

The FDA has extended the review period for Optinose's sNDA seeking approval of Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis in patients without nasal polyps, Optinose said. Xhance was originally approved by the FDA in 2017 for the treatment of nasal polyps. The agency originally accepted the sNDA in May 2023 and set a PDUFA goal … [Read more...] about FDA extends review period for Optinose’s sNDA for Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis

FDA issues warning letter to Cipla citing significant problems at inhaler manufacturing facility, including continued production of defective MDIs

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

Ethris gets approval for Phase 1 trial of ETH47 inhaled mRNA

According to Ethris, a clinical trial authorization (CTA) that the company submitted to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in June 2023 has been approved, and Ethris expects to initiate a Phase 1 clinical trial of its ETH47 inhaled mRNA in healthy participants before the end of the year. The company is developing ETH47 as for the … [Read more...] about Ethris gets approval for Phase 1 trial of ETH47 inhaled mRNA

FDA accepts Orexo’s NDA for OX124 intranasal dry powder naloxone for the treatment of opioid overdose

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

Lupin launches Vilfuro-G triple combination DPI in India

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

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

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