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Waiver Aids Luye’s US Approval Quest For Risperdal Consta Rival

This article was originally published in PharmAsia News

Executive Summary

Luye has obtained a Phase III study waiver from the US FDA for its risperidone microsphere product, in a major step towards expediting the filing and potentially first US approval of a value added China-developed drug, which stands to become a rival to J&J’s Risperdal Consta.

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