Home » HGS Gets Discipline Review Letter in Response to BLA for Zalbin
HGS Gets Discipline Review Letter in Response to BLA for Zalbin
The future of Human Genome Sciences’ (HGS) hepatitis C candidate Zalbin is in doubt as the FDA questions the risk-benefit profile of the biologic. Although the candidate has a user fee action goal date of Oct. 4, the FDA issued a discipline review letter, saying the agency has concerns about Zalbin (albinterferon alfa-2b) dosed at 900 mcg every two weeks, HGS said. A discipline review letter is an instrument the FDA uses to convey early thoughts on possible deficiencies in an NDA or BLA.
Washington Drug Letter
Washington Drug Letter
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