Psycho-Babble Medication Thread 1096706

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Solriamfetol (jzp-110) DNRI: NDA submitted Dec '17

Posted by PeterMartin on January 23, 2018, at 21:51:01

I had posted a thread last year about jzp-110 (reuptake inhibitor of dopamine and norepinephrine) which was in phase III trials for narcolepsy. (http://www.dr-bob.org/babble/20161215/msgs/1094144.html)

I just discovered an NDA was submitted to the FDA for this drug (now called Solriamfetol) on December 21, 2017. Maybe it'll help some people here down the road if it gets approved.

How long does the NDA process take? 6months?

https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-submits-new-drug-application-for-solriamfetol-jzp-110-for-excessive-sleepiness-associated-with-narcolepsy-and-obstructive-sleep-apnea-300574389.html

Re: Solriamfetol (jzp-110) DNRI: NDA submitted Dec '17

Posted by Hugh on January 24, 2018, at 14:23:57

In reply to Solriamfetol (jzp-110) DNRI: NDA submitted Dec '17, posted by PeterMartin on January 23, 2018, at 21:51:01

The FDA has 6 to 10 months to make a decision.

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