Allergan announces FDA approval of updated label for Teflaro (ceftaroline fosamil)

FDA

2 September 2015 - Allergan plc. today announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental new drug application (sNDA) to update the label for Teflaro (ceftaroline fosamil) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The approved label contains new clinical data from two ABSSSI trials that included patients with baseline Staphylococcus aureus bacteremia. Bacteremia is the presence of bacteria in the bloodstream. Bacteremia complicates infection treatment and in the most serious cases, can be fatal.

With this updated label, Teflaro also is now approved to be administered by intravenous (IV) infusion in five minutes to one hour in adult patients 18 years and older.

For more details, go to: http://www.allergan.com/news/news/thomson-reuters/allergan-announces-fda-approval-of-updated-label-f

Michael Wonder

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Michael Wonder