The counterfeit products were procured from unauthorized distributors.
The allocation and distribution of vaccine is being managed by the Department of Defense, in partnership with agencies within the Department of Health and Human Services.
This is the first time the Agency has authorized a COVID-19 diagnostic test that provides rapid results at home.
The FDA also approved Vimpat Injection for use in pediatric patients 4 years of age and older.
The investigational treatment, which is administered as a monthly intravenous infusion, binds to aggregated β-amyloid and promotes removal of amyloid from the brain.
The trial will continue as planned and final analysis is expected when the number of confirmed COVID-19 cases reaches 164.
ALKS 3831 is composed of samidorphan, a mu-opioid receptor antagonist, which is co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.
Apomorphine is believed to treat off episodes associated with PD through stimulation of postsynaptic dopamine D2-type receptors within the caudate-putamen in the brain.
The FDA has approved Enspryng (satralizumab-mwge; Genentech) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
The FDA has accepted for Priority Review the Biologics License Application for aducanumab for the treatment of Alzheimer disease.
