Alexza’s Revised Adasuve REMS Borrows From Risk Management Plan For Zyprexa Relprevv
This article was originally published in The Pink Sheet Daily
A resubmitted Risk Evaluation and Mitigation Strategy that proposes to limit use of inhaled loxapine to health care facilities with ready access to advanced airway support borrows from language in the REMS for Lilly’s long-acting intramuscular injection formulation of olanzapine, Alexza’s CEO says.
You may also be interested in...
Patient screening to ensure pulmonary risks are mitigated could be difficult in emergency room settings, advisory committee says about inhaled loxapine formulation.
Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.
‘Frontline’ Essential Workers, Persons 75 Years And Older Prioritized For Second Phase Of COVID Vaccination
Essential workers who cannot work remotely and have high levels of interaction with the public, and individuals ≥75 years old, should get vaccinated ahead of those 65-74 years old and those with comorbid conditions, CDC Advisory Committee on Immunization Practices recommends.