Feb. 10, 2016 /PRNewswire/ -- Vanda Pharmaceuticals (NASDAQ: VNDA), today announced financial and operational results for the fourth quarter and full year ended December 31, 2015.
"2015 was a transformational year for Vanda with the continued growth of HETLIOZ in the U.S., and the European market approval of HETLIOZ for Non-24," said Mihael H. Polymeropoulos, M.D., Vanda's President and CEO. "The addition of Fanapt to our U.S. product portfolio builds on this success and underscores Vanda's commitment to bringing important treatment options to patients."
HETLIOZ® net product sales were $44.3 million for the full year 2015, a 246% increase compared to $12.8 million reported for the full year 2014.
Fanapt® net product sales were $65.6 million for the full year 2015, compared to $65.0 million in 2014. In December 2015, the Marketing Authorization Application for oral Fanaptum® tablets was accepted for evaluation by the European Medicines Agency. The FDA review of the supplemental New Drug Application for Fanapt® for the maintenance treatment of schizophrenia in adults is ongoing. The FDA has set a PDUFA goal date in May 2016.
New Molecular Entity (NME) NDA and Original BLA
Priority Review: 8 months from submission date
Priorty Review: 6 months from submission date
Priorty Review: 8 months from submission date, for drugs that are a new molecular entity (nme).
Priorty Review: 6 months from submission date, for drugs that are non-nme.
The important thing is that this company is making good progress.