FDA gives tentative approval to Sun Pharma for generic Crestor


Sun Pharmaceutical Industries Ltd., based in Mumbai, is one of the largest drugmakers of India.  Sun Pharma revealed that Food and Drug Administration gave tentative approval for marketing of a generic version of AstraZeneca PLC’s cholesterol drug Crestor.  This drug is useful in treatment of various heart diseases.

Why is the approval tentative?
The patents that support Crestor, or rosuvastatin calcium will start expiring in 2016.  Thus, FDA approval is tentative as Sun can not sell the generic version of Crestor in the US, yet.

What sizes of generic drug have been approved?
Tablets of 5 milligrams, 10 milligrams, 20 milligrams, and 40 milligrams were given tentative approval.

How much is market for Crestor?
AstraZeneca is a London based company and...

got approval for Crestor in 2003.  U.S. sales of Crestor totaled $1.26 billion in the first half of 2010 and $2.73 billion worldwide.

Sun Pharma is looking at a market of billions of dollars by sale of its generic version of Crestor.

Source: Business Standard

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