Three Indian firms, Sun Pharma, Glenmark and Aurobindo, have received nod from the US health regulator Food and Drug Administration (FDA) to sell their generic versions of the blockbuster cholesterol drug Crestor in the American market.
IPR Pharmaceuticals Inc’s Crestor tablets had posted annual sales of around $6.78 billion in the 12 months ended May 2016.
The approval granted by the USFDA to three domestic firms for generic rosuvastatin calcium tablets are for strengths of 5 mg, 10 mg, 20 mg and 40 mg.
Aurobindo pharma was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification. Therefore, the company “is eligible for 180 days of generic drug shared exclusivity. The product is launched in the US market”, it said.
Both Sun Pharma and Glenmark said the approvals for their generic generic rosuvastatin calcium tablets have been granted to their respective subsidiaries in the US.
Crestor is used to lower cholesterol and fats (triglycerides) in blood and is used to reduce the chances of developing problems such as heart disease and strokes.