3 cos get USFDA nod to launch drug of AstraZeneca


Mumbai: Aurobindo, Glenmark and Sun Pharma shares surged by up to 5% on Wednesday after the firms got US health regulator’s nod to sell their generic versions of AstraZeneca’s cholesterol drug Crestor in the American market. Aurobindo Pharma jumped 5.1% to settle at Rs 797.9 on BSE. Glenmark Pharma went up by 2.4% to Rs 853.1 and Sun Pharma rose by 1.9% to Rs 797.
IPR Pharmaceuticals Inc’s Crestor tablets had posted annual sales of around $6.8 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 and Glenmark said the approvals for their generic rosuvastatin calcium tablets have been granted to their subsidiaries in the US. Crestor is used to lower cholesterol and fats (triglycerides) in blood and is used for reducing the chances of developing problems such as heart disease and strokes.
A US judge on Tuesday refused to issue a temporary restraining order blocking the approval of new generic versions of AstraZeneca’s blockbuster cholesterol drug Crestor in the United States.
US District Judge Randolph Moss in Washington, DC ruled that AstraZeneca was not likely to win a lawsuit claiming it should get seven more years of exclusive rights to the drug thanks to its recent approval to treat a rare pediatric illness.AstraZeneca spokeswoman Michele Meixell said in an emailed statement the company was “disappointed” with the decision.

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