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FDA approves first generic rosuvastatin Posted 13/05/2016

The US Food and Drug Administration (FDA) announced on 29 April 2016 that it had approved the country’s first generic version of Astra Zeneca’s leading cholesterol drug Crestor (rosuvastatin).

The generic rosuvastatin from Allergan (formerly Watson Pharmaceuticals and Actavis), has been approved by FDA for the following uses:

  • in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults;
  • in combination with diet for treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder associated with improper breakdown of cholesterol and triglycerides;
  • either alone or in combination with other cholesterol treatment(s) for adult patients with homozygous familial hypercholesterolemia, a disorder associated with high low-density lipoprotein (LDL) cholesterol. 

Rosuvastatin calcium belongs to a class of drugs called statins, which work by stopping an enzyme called 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase from making cholesterol. Statins reduce levels of ‘bad cholesterol’ (LDL) and triglycerides in the blood, while increasing levels of ‘good cholesterol’ [high-density lipoprotein (HDL)].

High LDL cholesterol, the so-called ‘bad cholesterol’, is a known risk factor for heart attacks, strokes and heart disease. High triglycerides may also increase the risk of heart disease. Approximately 71 million American adults (33.5%) have high LDL, or ‘bad cholesterol’.

Under the terms of an agreement between Allergan and AstraZeneca made on 25 March 2013, Allergan has launched its generic version of Crestor 67 days prior to 8 July 2016, the expiration of paediatric exclusivity.

Allergan claims that it is the first-to-launch generic rosuvastatin and expects this to be the ‘the largest generic launch in 2016’. For the 12 months ending 31 March 2016, Crestor had total US sales of approximately US$6.5 billion, according to IMS Health.

India-based Sun Pharmaceutical Industries gained tentative approval from FDA for its generic version of Crestor (rosuvastatin) in September 2010 [1]. While generics giant Mylan Pharmaceuticals received approval from Health Canada for a generic version of Crestor (rosuvastatin) in March 2012 [2].

Related article
Generic atorvastatin may be better than Crestor

References
1. GaBI Online - Generics and Biosimilars Initiative. Sun gains tentative approval for generic Crestor [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 13]. Available from: www.gabionline.net/Generics/News/Sun-gains-tentative-approval-for-generic-Crestor
2. GaBI Online - Generics and Biosimilars Initiative. Generic rosuvastatin approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 13]. Available from: www.gabionline.net/Generics/News/Generic-rosuvastatin-approved-in-Canada

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Source: Allergan, US FDA

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