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DUBLIN, Ireland — Allergan plc has received final approval from the Food and Drug Administration for rosuvastatin calcium tablets, a cholesterol-lowering medication.
The company said its rosuvastatin calcium product comes in dosages of 5 mg, 10 mg, 20 mg and 40 mg and is a generic version of Crestor tablets from AstraZeneca.
Allergan noted that the approval will make it the first company to launch a generic version of Crestor to customers in the United States. Under the terms of an agreement reached with AstraZeneca on March 25, 2013, Allergan launched its Crestor generic 67 days before July 8, 2016, the expiration of pediatric exclusivity.
“This first-to-market launch demonstrates the talent of our generics team in developing, manufacturing and bringing to market high-quality, affordable versions of widely used medications like Crestor,” stated Robert Stewart, executive vice president and president of generics and global operations at Allergan. “This is expected to be the largest generic launch in 2016, benefiting patients and reducing cost for U.S. health systems.”
A statin drug, rosuvastatin lowers levels of “bad” cholesterol (low-density lipoproteins, or LDLs) and triglycerides in the blood while raising levels of “good” cholesterol (high-density lipoproteins, or HDLs).
For the 12 months ended March 31, Crestor totaled U.S. brand sales of about $6.5 billion, according to IMS Health data reported by Allergan.
