According to Polarean Imaging, the FDA has approved the company's NDA for its Xenoview inhaled xenon-129 gas blend, a hyperpolarized contrast agent for MRI imaging of lung ventilation. Xenoview is approved for use in patients aged 12 and over. The agency also cleared two Polarean 510(k)s, one for a chest coil "intended to be worn by a patient who inhales … [Read more...] about FDA approves Polarean’s inhaled hyperpolarized contrast agent for lung ventilation imaging
Regulatory
FDA accepts Harm Reduction’s NDA for RiVive intranasal naloxone and grants Priority Review designation
According to Harm Reduction Therapeutics, the FDA has accepted the company's NDA for its RiVive naloxone nasal spray for the reversal of opioid overdose and granted the NDA Priority Review designation. Harm Reduction had announced the initiation of a rolling NDA submission for RiVive in October 2022. The company says that the FDA has set April 28, 2023 as the goal … [Read more...] about FDA accepts Harm Reduction’s NDA for RiVive intranasal naloxone and grants Priority Review designation
Virpax says it has received FDA guidance regarding clinical development of NobrXiol cannabidiol nasal powder
According to Virpax Pharmaceuticals, the FDA has provided guidance in response to the company's pre-Investigational New Drug NobrXiol (VRP324) CBD nasal powder, which Virpax is developing for the for the treatment of epilepsy. In September 2021, Virpax announced that it had acquired exclusive worldwide rights to Nanomerics’s molecular envelope technology (MET) for use … [Read more...] about Virpax says it has received FDA guidance regarding clinical development of NobrXiol cannabidiol nasal powder
FDA clears Vertex’s IND for VX-522 inhaled mRNA therapy for CF
Vertex Pharmaceuticals said that it plans to initiate a Phase 1 SAD trial of its VX-522 inhaled mRNA therapy after the FDA cleared the company's IND. VX-522 contains lipid nanoparticle-encapsulated mRNA that is designed to treat cystic fibrosis in patients who do not produce cystic fibrosis transmembrane conductance regulator (CFTR) and are therefore not helped by a … [Read more...] about FDA clears Vertex’s IND for VX-522 inhaled mRNA therapy for CF
FDA accepts Emergent Biosolutions sNDA for OTC Narcan naloxone nasal spray
According to Emergent BioSolutions, the FDA has accepted the company's supplemental NDA for over-the-counter (OTC) sales of Narcan naloxone nasal spray for the reversal of opioid overdose and has set a PDUFA goal date of March 29, 2023. The sNDA is for a 4mg dose of Narcan, which is the original strength. In 2017, the FDA also approved a 2 mg dose, which has since … [Read more...] about FDA accepts Emergent Biosolutions sNDA for OTC Narcan naloxone nasal spray
Vistagen’s PH10 nasal spray gets Fast Track designation
The FDA has awarded Fast Track designation to Vistagen's PH10 pherin nasal spray for the treatment of major depressive disorder, the company said. Vistagen recently announced its plans for a Phase 1 trial of a re-formulated version of PH10 expected to begin in early 2023 after receiving a "Study May Proceed" letter from the agency. Vistagen CEO Shawn Singh said, … [Read more...] about Vistagen’s PH10 nasal spray gets Fast Track designation
FDA approves Aucta’s generic formoterol fumarate inhalation solution
The FDA has approved Aucta Pharmaceuticals' ANDA for its formoterol fumarate inhalation solution, a generic version of Mylan's Perforomist. Aucta's is the 4th Perforomist equivalent approved since the expiration of Mylan's final patent covering the inhalation solution. Teva launched its generic equivalent in the US in June 2021, and the FDA approved Alembic … [Read more...] about FDA approves Aucta’s generic formoterol fumarate inhalation solution
Adherium’s Hailie sensor gets 510(k) clearance for use with Ventolin, Advair, and Flovent MDIs
Adherium announced that the FDA has granted 510(k) clearance for use of Adherium's next-generation Hailie inhaler sensor with GSK's Ventolin, Advair, and Flovent MDIs. The company had announced submission of the 510(k) application in August 2022. Adherium CEO Rick Legleiter said, "This is the third 510(k) market clearance of the next-generation Hailie sensors … [Read more...] about Adherium’s Hailie sensor gets 510(k) clearance for use with Ventolin, Advair, and Flovent MDIs
Opiant completes rolling NDA submission for OPNT003 intranasal nalmefene
According to Opiant Pharmaceuticals, the submission of its NDA for OPNT003 nalmefene nasal spray for the treatment of opioid overdose has been completed, and the FDA's decision on acceptance of the application is expected in February 2023. The company announced that it had initiated the rolling NDA submission at the beginning of June 2022. Aptar Pharma’s Unit Dose … [Read more...] about Opiant completes rolling NDA submission for OPNT003 intranasal nalmefene
FDA solicits comments regarding a potential switch to nonprescription naloxone products, including nasal sprays
The FDA has issued a notice in the Federal Register titled, "Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use." The agency says that its preliminary opinion is that autoinjectors with doses up to 2 mg and nasal sprays with doses up to 4 mg such as Narcan nasal spray could be appropriately approved as nonprescription … [Read more...] about FDA solicits comments regarding a potential switch to nonprescription naloxone products, including nasal sprays