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Janssen R&D LLC

Division of Johnson & Johnson
www.janssenrnd.com

Latest From Janssen R&D LLC

REMS Statutory Factors Weighed On Case-By-Case Basis, US FDA Says

US FDA rebuffs PhRMA’s request to clarify how the six statutory factors are weighed and to explain how it decides what a REMS should look like. All six factors are considered together to inform agency’s decision-making on the need for a Risk Evaluation and Mitigation Strategy, according to final version of guidance first issued in 2016.


Risk Management Drug Safety

Zulresso Postmarket Commitment Hints At Easier Dosing In Postpartum Depression

US FDA wants Sage Therapeutics to explore Zulresso use in alternative settings in a postmarketing trial. A successful study could expand access to the new approved brexanolone, whose administration is now long, complicated, and restricted to certified healthcare facilities.
Approvals Neurology

Janssen’s Spravato Enters US Market With Enhanced REMS And Plans For A Monotherapy Trial

Restrictive risk management plan for antidepressant nasal spray requires patients be monitored for two hours after dosing and enroll in a patient registry; Janssen has agreed to conduct a monotherapy efficacy trial as a postmarketing commitment.

Approvals Drug Approval Standards

Takeda’s Uloric Gets CV Death Warning And Restricted Indication, But No REMS

Despite advisory committee pressure, US FDA stands firm against imposing REMS targeted at gout drug’s cardiovascular risks; however, Takeda must conduct utilization study to see if labeling changes impact prescribing patterns.

Drug Safety Post Market Regulation & Studies
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