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Cerus Corporation (NASDAQ:CERS) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of 12-month shelf life for INTERCEPT Platelet Processing Sets, from the date of manufacture, effective immediately. This approval extends the set shelf life by six months from the existing six-month shelf life that took effect following a set component change last year. All INTERCEPT Platelet Processing Sets in both customer and Cerus inventories are now eligible for this six-month extension. This shelf-life extension applies to all sizes of INTERCEPT Platelet Processing Sets currently available in the U.S.
"We are pleased with this successful and timely outcome to our regulatory filing with the FDA to re-establish a longer shelf life for INTERCEPT Platelet Processing Sets in the U.S.," said Vivek Jayaraman, Cerus' chief operating officer. "We expect that this extension will provide relief to our customers' and our supply chains and will give customers the flexibility to balance inventory levels with current and future demand while reducing product expiration risk."
The Company is continuing to generate additional data to pursue potential shelf life extension from the FDA beyond 12 months for the INTERCEPT Platelet Processing Sets.
Posted In: CERS
