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Zalbin FDA Approval Status

FDA Approved: No
Brand name: Zalbin
Generic name: albinterferon alfa-2b
Company: Human Genome Sciences, Inc.
Treatment for: Hepatitis C

Zalbin (albinterferon alfa-2b) is a genetic fusion of human albumin and interferon alfa intended for the treatment of chronic hepatitis C.

In October 2010, Human Genome Sciences, Inc. (HGS) announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for Zalbin (albinterferon alfa-2b). HGS and Novartis have decided not to develop Zalbin further.

Development timeline for Zalbin

Oct  5, 2010Human Genome Sciences Receives Complete Response Letter from FDA on Zalbin BLA for Chronic Hepatitis C
Jun 14, 2010Human Genome Sciences Announces Preliminary Feedback From FDA on Zalbin BLA for Chronic Hepatitis C
Nov 25, 2009Human Genome Sciences Submits Biologics License Application to FDA for Zalbin

Further information

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