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Aurobindo Pharma receives FDA nod for rosuvastatin calcium tabs

Various medicine pills are seen in Ljubljana February 14, 2012.   REUTERS/Srdjan Zivulovic (SLOVENIA  - Tags: HEALTH)
Various medicine pills are seen in Ljubljana February 14, 2012. REUTERS/Srdjan Zivulovic (SLOVENIA - Tags: HEALTH)

New Delhi: Leading Indian pharmaceutical company Aurobindo Pharma has announced receiving the final approval from the US health regulator USFDA for rosuvastatin calcium tablets, used in lowering cholesterol.

In a BSE filing, the company said that it has finally got a nod by the US Food and Drug Administration (US FDA) for rosuvastatin calcium tablets.

“Aurobindo was one of the first applicants to submit a substantially complete ANDA with a paragraph IV certification and hence, it is eligible for 180 days of generic drug shared exclusivity,” it further added.

Rosuvastatin calcium tablets are generic version of Crestor tablets of IPR Pharmaceuticals, Inc., and the approval has been granted in the strength of five mg, 10 mg, 20 mg and 40 mg.

Crestor is used to lower cholesterol and fats (triglycerides) in the blood and is used to reduce the chances of developing problems such as heart disease and strokes.

Presently, Aurobindo Pharma holds a total of 274 ANDA approvals (234 final approvals including 13 from Aurolife Pharma LLC and 40 tentative approvals) from the US.

The stock of Aurobindo Pharma was seen trading 3.87 percent higher at Rs. 788.65 on the BSE after approval. (ANI)

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