The FDA issued a warning letter to Nose Slap LLC for marketing these unapproved drugs.
Akorn ceased and shutdown all operations following a Chapter 7 bankruptcy filed on February 23, 2023.
Approval of the modified Opioid Analgesic REMS is expected in 2024.
Narcan Nasal Spray for OTC use is expected to be available by late summer and will have the same formulation, device design, and 4mg strength as the prescription product.
Lumateperone 42 mg given once daily met the primary endpoint in the study.
Inspire therapy is a fully implanted neurostimulation device that consists of a small generator, a sensing lead, and a stimulation lead.
KarXT is an oral, investigational therapy that combines xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist.
Solanezumab is a humanized monoclonal antibody designed to increase clearance of soluble amyloid beta (Aβ) from the brain by binding to aggregated forms of Aβ.
The product was designed using the Amphastar’s proprietary nasal delivery device.
The sBLA is supported by data from the confirmatory phase 3 Clarity AD trial, which included patients with early Alzheimer disease.
While not approved for human use, xylazine has been detected in combination with opioids (eg, illicit fentanyl), and with stimulants (eg, methamphetamine, cocaine).
The BLA is supported by data from a phase 3 trial which included approximately 7400 pregnant individuals.
Narcan Nasal Spray is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension.
Gadopiclenol only requires half of the gadolinium dose of conventional nonspecific GBCAs.
A PDUFA target date of August 5, 2023 has been set for the application.
OPNT003 is an intranasal formulation containing the high affinity opioid antagonist, nalmefene.
The approval was based on data from adequate and well-controlled studies with risperidone long-acting injection (intramuscular).
Nirsevimab is a long-acting anti-RSV for nirsevimab for the prevention of RSV lower.
The MAPP2 study included 104 patients who received either MDMA or placebo plus psychotherapy.
BresoDX1 is designed to record a patient’s physiological signals during sleep using a sensor and a pulse oximeter.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.
RiVive is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension.
The study included approximately 400 adults with a history of bipolar I disorder who had a current episode of mania.
Detect, Inc. is voluntarily recalling specific lots of the Detect COVID-19 Test™ due to an increased risk of false negative results.
The bivalent formulations contain the original strain of the SARS-CoV-2 virus and a strain from the BA.4 and BA.5 lineages of the Omicron variant.
The designation is supported by data from 3 clinical studies.
The resubmitted NDA was in response to a Complete Response Letter issued by the FDA in December 2021.
If approved, the OTC nasal spray would deliver 4mg of naloxone per spray.
The BLA is supported by data from the phase 3 RENOIR trial which included approximately 37,000 adults 60 years of age and older.
AXS-05 is an investigational agent consisting of a proprietary formulation of dextromethorphan and bupropion.
