MARLBOROUGH, Mass. — The Food and Drug Administration has approved a drug made by Sunovion and Dainippon Sumitomo Pharma Co. for bipolar disorder, Sunovion said Monday.
The FDA has approved Latuda (lurasidone hydrochloride) for use either alone or combined with lithium or valproate in patients with bipolar depression. The drug was already approved for treating schizophrenia.
"These two approvals represent a significant milestone not only for Sunovion and DSP, but for the millions of Americans who are living with bipolar disorder and struggling to manage the symptoms of bipolar depression," DSP president, CEO and representative director Masayo Tada said. "We look forward to building on the strong foundation started in the United States to bring Latuda to other markets around the world."