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-   -   Acorda receives refusal to file letter from FDA for Inbrija (https://www.neurotalk.org/parkinson-s-disease/249020-acorda-receives-refusal-file-letter-fda-inbrija.html)

rainbow676 08-29-2017 04:25 PM

Acorda receives refusal to file letter from FDA for Inbrija
 
This was disappointing to see:

Acorda Therapeutics Inc - Acorda Receives Refusal to File Letter from FDA for INBRIJA™ (CVT-31, levodopa inhalation powder) New Drug Application

Fortunately, it seems that Acorda should be able to provide the additional information, but it is unfortunate that there will be a delay. Oral Sinemet is going badly for my mom these days and we were very keen to try another delivery route (not much luck with agonists either, and she is currently trying Xadago).

Did anyone on the forum participate in the trial, and if so, would you be willing to share your experiences?

Thanks.


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