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.