FDA Rejects Teva Huntington Disease NDA

Jun 02, 2016

The U.S. FDA has rejected a new drug application from Teva Pharmaceutical, asking the drugmaker for more information regarding blood levels of certain metabolites.

Teva received a Complete Response Letter from the FDA regarding the NDA for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease.

The FDA did not request new clinical trials. Teva said it would respond during the third quarter.

Teva acquired SD-809 in April of last year when the drugmaker bought Auspex Pharmaceuticals in a deal worth roughly $3.5 billion.

Read the press release