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It has shown efficacy and good tolerability in a phase II study in DPN and based on the results of two phase III placebo-controlled trials in DPN and post-herpetic neuralgia a producer of mirogabalin submitted a marketing application for DPN in Japan that has been approved in 2019

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In March 2023, Iovance finally completed a rolling BLA submission, which the FDA accepted in May, setting the late November action date

However, it is important to note that berberine is classified as a food supplement in the UK, not a licensed medicine, and is therefore not subject to the same rigorous regulatory standards as prescription drugs

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