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The End of an Era: Lipitor, Blockbuster Drugs and the Waxman/Hatch Model

This article was originally published in RPM Report

Executive Summary

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.

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Culture Clash: U.S. FDA Tries to Re-educate Indian Firms on Processes And Accurate Reporting

FDA has essentially shut down Ranbaxy’s three-year-old facility at Mohali as a source for products for the US market. But Ranbaxy is not alone among Indian firms in its quality product disputes with the agency. There is a significant uptick in activity by FDA in the region in what appears to be a period of intense culturization for the Indian firms into the ways FDA enforces cGMPs and handles on-site inspections.

Culture Clash: FDA Tries to Re-Educate Indian Firms on Processes and Accurate Reporting

FDA has essentially shut down Ranbaxy’s three-year-old facility at Mohali as a source for products for the US market. But Ranbaxy is not alone among Indian firms in its quality product disputes with the agency. There is a significant uptick in activity by FDA in the region in what appears to be a period of intense culturization for the Indian firms into the ways FDA enforces cGMPs and handles on-site inspections.

Ranbaxy Halts Atorvastatin Production; Too Late for Mylan to Say “I Told You So?”

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.

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