Oct 25 2010
ViroPharma Incorporated (Nasdaq: VPHM) today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding Cinryze™ (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. The FDA has requested additional information related to observations from the pre-approval inspection and review of the technical processes.
"We and our partner Sanquin will begin working immediately to respond to the FDA as expeditiously as possible," said Vincent Milano, ViroPharma's president and chief executive officer. "And, we plan to commence manufacturing industrial scale lots at risk in the first quarter of 2011."
Continued Milano, "We remain committed to provide patients with an uninterrupted supply of Cinryze. In addition to our efforts around our industrial scale, we expect our currently approved manufacturing process alone will yield up to 60,000 doses annually."
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