Ranbaxy Halts Atorvastatin Production; Too Late for Mylan to Say “I Told You So?”
This article was originally published in RPM Report
One year after the biggest generic drug launch in history, Ranbaxy is halting production of atorvastatin after a manufacturing quality glitch. FDA should be grateful this didn’t happen in the first six months – but may also want to start preparing for possible investigations if the new Energy & Commerce/Oversight chairman decides to press a point.
You may also be interested in...
Mylan played a pivotal role in crafting the formula to create Generic Drug User Fees. The selection of Rep. Tim Murphy (R-Pa.) to chair the House Energy & Commerce Oversight Subcommittee should help assure that Mylan’s perspectives continue to play an important role.
Pfizer’s Lipitor goes generic—albeit with some decidedly unusual wrinkles. The biggest generic launch in history is a good moment to take stock of the transition away from the blockbuster model. The reaction to the milestone suggests that the industry’s critics may be having a harder time letting go of the old model than industry is.
The world’s best-selling prescription drug is about to lose patent protection, presenting generic drug companies with their biggest marketing opportunity ever. But potential fraud by first-filer Ranbaxy is complicating the generic landscape for Pfizer’s Lipitor. The stakes are high: How FDA resolves the Ranbaxy debacle will not only determine the winners of the Lipitor battle, but could drive big changes to the generic drug law.