The review may take up to nine months. The FDA is reviewing other leukotriene modifying medications on reports of similar side effects.
REGULATORY REVIEW. Alerts, warnings and recalls. The boxed warningfor rosiglitazone(Avandia) was re-vised to reflect a potentialincreased risk of heart attacks. ... Antifibrinolytic drug aprotinin injec-tion (Trasylol) was temporarily pulledfrom the
The FDA should have priority regulatory review for applications for these types of products. .
Warnings, recalls, label changes, and approvals.
And let us know what you think of our new staff columns: Web Watch, Regulatory Review and The Campaign Trail.
Jessica] Berthold's column regarding alerts, warnings and recalls as well as approvals in the Regulatory Review column.
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