The review may take up to nine months. The FDA is reviewing other leukotriene modifying medications on reports of similar side effects.
The FDA should have priority regulatory review for applications for these types of products.
Warnings, recalls, label changes, and approvals.
REGULATORY REVIEW. Alerts, warnings and recalls. The boxed warningfor rosiglitazone(Avandia) was re- vised to reflect a potential increased risk of heart attacks. ... Antifibrinolytic drug aprotinin injec- tion (Trasylol) was temporarily pulled from the
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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