Three Indian firms get USFDA nod for cholesterol drug

Aurobindo, Glenmark and Sun Pharma got USFDA nod to sell Crestor in the US market.

The Dollar Business Bureau

Three Indian companies, Aurobindo Pharma, Glenmark and Sun Pharma, have got the approval from the USFDA (United States Food and Drug Administration) to sell the generic versions of the famous drug Crestor prescribed for cholesterol, in the US market

The nod, given by the US health regulator to these three domestic companies, is for the generic rosuvastatin calcium tablets in 5 mg, 10 mg, 20 mg and 40 mg strengths. 

“We are one of the first ANDA (Abbreviated New Drug Application) applicants to file a significantly complete application with a paragraph IV certification. Hence, we are eligible for six months shared exclusivity of the generic drug. The drug is launched in the American market,” Aurobindo Pharma said in a statement. 

The other two companies, Glenmark and Sun Pharma, said that the nod for the generic tablets - rosuvastatin calcium has been given to their respective arms in the US. 

“One of Sun Pharma subsidiaries has got the final nod from the US health regulator for its generic version of the drug Crestor - rosuvastatin calcium tablets - in 5 mg (base), 10 mg (base), 20 mg (base) and 40 mg (base) strengths,” Sun Pharma stated in release.

These rosuvastatin calcium tablets are therapeutic equivalents of IPR Pharmaceuticals Inc’s Crestor tablets. According to IMS MAT May 2016, these Crestor tablets have a yearly sale of around $6.8 billion in the US market, in the 12 months period ended on May 2016.

Crestor tablets are used in lowering the triglycerides (cholesterol and fats) in the blood and to lessen the probability of developing problems like heart disease and strokes.

The Dollar Business Bureau - Jul 20, 2016 12:00 IST