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FDA wants more info on Sunovion Parkinson’s therapy

January 31, 2019 8:36 PM UTC

Sunovion Pharmaceuticals Inc. said late Wednesday that FDA issued a complete response letter for its NDA for apomorphine sublingual film (APL-130277) to treat "off" episodes in Parkinson’s disease patients.

The subsidiary of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said FDA requested additional information and analyses, but no new clinical studies are required...