04.02.2015 14:11:41
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Actavis Says FDA Accepts SNDA To Expand TEFLARO Labeling - Quick Facts
(RTTNews) - Actavis Plc. (ACT) Wednesday said the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application or sNDA to expand the label for TEFLARO (ceftaroline-fosamil) to treat cases of concurrent bacteremia in patients with acute bacterial skin and skin structure infections or ABSSSIs, caused by susceptible isolates of Staphylococcus aureus that include Methicillin-susceptible and resistant isolates.
Concurrent bacteremia is a secondary infection that occurs when bacteria spreads from the primary site of infection to the blood stream. Concurrent bacteremia complicates infection treatment can turn out to be fatal.
The sNDA submission was based on a subset of data coming from two identical pivotal trials - CANVAS 1 and 2 - comparing ABSSSI patients treated with TEFLARO monotherapy to patients treated with vancomycin plus aztreonam.
Clinical response was evaluated at Test of Cure or TOC and Study Day 3 in subjects who had S. aureus bacteremia at baseline in the microbiological modified intent-to-treat (mMITT) population.
TEFLARO patients showed a comparable response at TOC of 90 percent and higher response at Study Day 3 of 65 percent, compared to patients treated with vancomycin/aztreonam.
Under the Prescription Drug User Fee Act, the FDA has set a target of third quarter of 2015 to complete its review.
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