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news.Aurobindo Pharma, a manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, has received FDA tentative approval for Rosuvastatin calcium tablets 5mg, 10mg, 20mg and 40mg that are generic equivalents of IPR Pharmaceuticals' Crestor tablets 5mg, 10mg, 20mg and 40mg.
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Rosuvastatin calcium is indicated for the treatment of high LDL cholesterol (dyslipidemia), total cholesterol (hypercholesterolemia) and/or triglycerides (hypertriglyceridemia) and falls under the CardioVascular (CVS) therapeutic category.
Aurobindo Pharma said that the tentatively approved ANDA no 079170 for Rosuvastatin calcium tablets was filed with Paragraph IV certification and is currently under litigation in the US district court for the district of Delaware (AstraZenca Pharmaceuticals, AstraZenca UK, IPR Pharmaceuticals and Shionogi Seiaku Kabushiki Kaisha vs Aurobindo Pharma and Aurobindo Pharma US, Civil Action no 08-MD-01949).
Aurobindo Pharma claimed that it now has a total of 116 ANDA approvals (86 final approvals and 30 tentative approvals) from the FDA.