Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC Dis­trict Court Judge Christo­pher Coop­er to­day grant­ed Van­da Phar­ma’s re­quest to re­quire the FDA to dis­close more in­fo on the com­plete re­sponse let­ter for its sleep dis­or­der drug Het­lioz.

The mela­tonin re­cep­tor ag­o­nist is ap­proved by the FDA to treat non-24-hour sleep-wake dis­or­der, a cir­ca­di­an rhythm dis­or­der. But in 2018 Van­da filed a sup­ple­men­tal ap­pli­ca­tion to mar­ket Het­lioz as a treat­ment for jet lag, which the FDA re­ject­ed in Au­gust 2019, with few de­tails on what Van­da need­ed to cor­rect course, ac­cord­ing to the com­pa­ny.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.