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Lyrica Generics Likely Delayed By A Pfizer Labeling Supplement

 
• By Derrick Gingery

US FDA's last-minute approval may have allowed Pfizer three more weeks of sales without competition.

stopping the Dominio effect
A labeling update approved just before patent expiry may have caused Lyrica generics to be cleared later than expected in the US . • Source: Shutterstock

An well-timed labeling update by Lyrica sponsor Pfizer Inc. appears to have allowed the company to squeeze a few more days of monopoly conditions out of the product in the US before generic competition arrived.

Patent protection on Lyrica (pregabalin) was set to expire 30 June and nine generic companies were ready with competitors. But...

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• By Sarah Karlin-Smith and Derrick Gingery

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Generic Drug Office’s Policy Staff Returning To US FDA

 
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The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.