Generic Lipitor Era Dawns With Watson’s Launch, Followed By Ranbaxy’s Last-minute Approval
This article was originally published in The Pink Sheet Daily
Teva will share in Ranbaxy’s profits during its exclusivity period, as FDA announces approval of Ranbaxy’s first-filed ANDA more than 14 hours after Watson discloses that it began shipping its atorvastatin “authorized generic”.
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Teva’s readiness for approval prompts FDA conclusion that Ranbaxy forfeited its rights to 180-day exclusivity for AstraZeneca’s proton pump inhibitor; Ranbaxy is still making its case in court, but episode is suggestive of FDA’s increasing emphasis on application quality.
Capital allocation and business re-structuring dominated the conversation during Pfizer’s Q1 earnings call –its first full quarter without Lipitor exclusivity, even as the company waits for near-term regulatory decisions on key compounds.
Ranbaxy’s $500 Million GMP Settlement Would Be Second Most Expensive For Rx Manufacturing Violations
Ranbaxy Laboratories said it has signed a consent decree with FDA and set aside $500 million to settle a related Department of Justice investigation involving GMP violations and data integrity issues at its Indian facilities.