Ranbaxy gets USFDA nod

5 December 2011: Ranbaxy Laboratories has got the US drug regulator's nod to sell its low-cost version of the world's best selling drug Lipitor in the US just in the nick of time after it clinched the regulator's nod hours before the cholesterol lowering drug's patent expires. The approval marks an end to the months of uncertainty and the secrecy surrounding the approval of the drug which could earn Ranbaxy over $500 million (approx Rs.2,569 crore) during an exclusive 6-month period in the US.

The company has received approval to make generic atorvastatin calcium tablets (chemical name of Lipitor) in 10 milligram, 20 mg, 40 mg, and 80 mg strengths. The drug will be manufactured by Ohm Laboratories in New Brunswick, New Jersey. The cholesterol medicine is the best selling drug of all time with annual sales of $11 billion, more than half of it coming from the US market alone. Its patent expired on November 30. The company has been in talks with both FDA and DoJ for a comprehensive settlement since 2009 to end three year old regulatory issues.

Source: Economic Times