In a significant development pharmaceutical major, Ranbaxy Laboratories has received approval from the US Food and Drug Administration (FDA) to launch the generic version of Lipitor an anti-cholesterol drug in the US market. The company was expecting delay in the launch of the drug as the FDA had earlier blacklisted some of its plans in India. The US patent of Pfizer for the `Lipitor’ medicine has expired recently and Ranbaxy and Watson Pharmaceuticals are the only two firms licensed to sell the product in the next six months. Watson is expected to launch the product this week but Ranbaxy was still trying to get the approval.
Two of Ranbaxy’s plants in India situated at Dewas and Paonta Sahib were blacklisted by the US FDA in 2008. The US FDA had also banned sale of 30 drugs as well as the approvals for new ones that are produced at the plant. This had caused concerns in the company, which was aiming to generate high revenues from the sale of the drug in the exclusive period.
Lipitor is estimated to generate about $700 million for Ranbaxy during the next six months of exclusive period. The company received approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths. The generic version will be manufactured by Ohm Laboratories in New Brunswick, N. J., according to a release by the FDA.
Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research said, “This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options. We are working very hard to get generic drugs to people as soon as the law will allow.”