Teva's Austedo gains second regulatory approval, now in China

Israeli generics giant Teva Pharmaceutical Industries (NYSE: TEVA) today announced that the China National Medical Products Administration (NMPA) has granted priority review approval for Austedo (deutetrabenazine tablets) one of its latest original medicines, for the treatment of chorea associated with Huntington's disease (HD) and tardive dyskinesia (TD) in adults.

China is the second country after the USA to have approved Austedo, said Teva, whose Tel Aviv listed shares were up 2.7% at 4,098 shekels by close of trading following its announcement and up 3.37% at $11.59 by mid-morning in New York.

As part of the expedited review process, the NMPA placed Austedo on the List of Overseas New Drugs Urgently Needed in Clinical Settings (the First Batch) and granted it priority review, ultimately completing the approval process in four months for the benefit of Chinese patients. This is the second approval and expected launch in China of a Teva specialty medicine, following the recent launch of Treanda (bendamustine). Teva will commercialize the medicine in China independently.