At this time, there have been no reports of adverse events related to this recall.
The FDA evaluation included an analysis of safety, effectiveness and manufacturing data of these vaccines.
According to the CDC, as of June 7, 2022, there have been over 13.1 million cases of COVID-19 among children and adolescents 0 to 17 years of age.
NVX-CoV2373 is engineered from the genetic sequence of SARS-CoV-2 using the Company’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein.
Dulaglutide is a glucagon-like peptide-1 receptor agonist.
Melatonin is a widely available over-the-counter dietary supplement used as a sleep aid for both adults and children.
Omaveloxolone is an investigational Nrf2 activator.
The approval was based on data demonstrating a high degree of similarity of Fylnetra to the reference product, with no clinically meaningful differences.
TTI-101 is an orally-delivered, small molecule, STAT3 (signal transducer and activator of transcription 3) inhibitor.
Perrigo received final approval to manufacture Omeprazole Magnesium Delayed-Release Mini Capsules, 20mg.
