WASHINGTON (dpa-AFX) - ViroPharma Inc. (VPHM) announced the U.S Food and Drug Administration issued a complete response letter regarding Cinryze (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities.
The company said that the FDA has three comments related to a portion of the cleaning validation for industrial scale manufacturing, of which only one requires additional unplanned activity.
The company noted that it expects that the additional activity required to address this comment can be completed in a short time frame.
According to the company, the FDA also noted that it has not yet completed the review of ViroPharma's January 2012 updated responses to observations specific to the September 2011 inspection of the Amsterdam facility. There are no remaining technical comments posed by FDA in the complete response letter.
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product. In the U.S., Cinryze is approved by the FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.
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