Quote:
Originally Posted by stanjay
Can you provide or direct me to any detailed info on the responses to the July 26 Form 483 and the changes made when Impax amended the CMC section of the Rytary NDA.
"The Company amended the chemical, manufacturing and control (CMC) section of the RYTARY NDA subsequent to its submission of responses to the July 26, 2014 Form 483 observations at the Taiwan facility. The FDA notified the Company that such amendment constituted a major amendment."
My wife had to stop Rytary 145 2 capsules 6 times per day (every 4 hour) because of severe dyskinesia which she never had while on
C/L 25/100. She went back on C/L and the dyskinesia gradually reduced and disappeared after 4 days.
stanjay
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Sorry stanjay, but I haven't seen the 483, or the subsequent extension.
Sorry to hear that your wife has had problems with it. All-in-all, most people I've spoken with that have started Rytary are quite happy with it. Some have had an adjustment period to get the dosage right. However, I've heard of a few stories, like yours, where it just could not be tolerating. I'm not sure why, but that is true with almost every drug.
Good luck!