PharmaLive: Pfizer Receives Approvable Letter from FDA for Dalbavancin
Here is the first of what I am sure will be plenty of approvable letter from the FDA this year. Pfizer received an approvable letter for dalbavancin, a once weekly two dose antibiotic useful for methicillin resistant bacteria. Note that this drug came to Pfizer by way of their acquisition of Vicuron.
PharmaLive: Pfizer Receives Approvable Letter from FDA for Dalbavancin :
Basically the FDA wants more evidence regarding non-inferiority as the basis for approval.
I personally think that antibiotics is NOT an area where the FDA needs to be seen as holding things up. With the rising number of MRSA infections occurring even outside the hospital the need for new antibiotics is growing and will continue to grow. Having been affected by this personally and knowing that only vancamycin worked in that case the need for new antibiotics will continue to be of concern.
Technorati Tags: dalbavancin, FDA, Pfizer
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