The FDA has licensed the pentavalent vaccine Penmenvy (GSK) for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W, or Y (MenABCWY) in persons 10-25 years old. Penmenvy is the second pentavalent meningococcal vaccine to become available in the US; Penbraya was licensed in 2023.1
MENINGOCOCCAL DISEASE — Six serogroups of N. meningitidis (A, B, C, W, X, and Y) cause most cases of invasive meningococcal disease worldwide. Most US cases are caused by serogroups B, C, and Y....
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RELEASE
The FDA has announced that prescribers, pharmacies, and patients are no longer required to participate in a Risk Evaluation and Mitigation Strategy (REMS) program for the second-generation antipsychotic drug clozapine (Clozaril, and others).1
Clozapine is generally considered the most effective antipsychotic drug for treatment of schizophrenia. It has been effective for treatment of psychotic symptoms that have not responded to other drugs and has been more effective than other antipsychotics in decreasing the risk of suicide.2
The REMS program for clozapine was instituted by the FDA in 2015 because of the risk of severe neutropenia associated with its use. Although absolute neutrophil count (ANC) monitoring is still recommended and a boxed warning about severe neutropenia will remain in the labels of all clozapine products, reporting ANC results …