FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Lehigh Valley Technologies to Settle Claims it Gamed User Fee Waivers

March 4, 2019
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Pennsylvania drugmaker Lehigh Valley Technologies agreed to pay $4 million to settle allegations of a conspiracy to illegally evade paying NDA fees.

The FDA grants waivers of user fees for small businesses submitting their first application, after considering any affiliates that may have already received a waiver.

According to the U.S. Attorney for the Eastern District of Pennsylvania, Lehigh received a waiver for its oxycodone hydrochloride NDA but then went on to secure two more waivers for NDAs relating to potassium chloride for oral solution.

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