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news.Citron Pharma confirmed that its licensing partner received final approval from the U.S. Food and Drug Administration (FDA) for their Abbreviated New Drug Application (ANDA) for Rosuvastatin Calcium 5, 10, 20 and 40 mg tablets, the generic version of AstraZeneca's CRESTOR (rosuvastatin calcium) tablets.
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Following FDA approval, Citron Pharma immediately commenced shipments of the generic version of CRESTOR to its customers in the U.S.
Ashok Mayya, Chief Operating Officer, noted, “Our team was on high alert preparing initial stocking quantities for launch to ensure the product could be shipped immediately following approval. The team did a remarkable job responding to the needs of our customers with a flawless launch. We’re on track to support 100% service levels for the product.”
Karen Strelau, Executive Vice President, Sales & Marketing, added, "Our customers expect this to be the largest generic launch in 2016. Citron responded by ensuring the highest level of customer service on initial shipments and stocking inventory.”
CRESTOR had U.S. sales of approximately $6.7 billion for the 12 months ending May 31, 2016, according to IMS Health.
CRESTOR is a licensed trademark of AstraZeneca.