Sunovion Pharmaceuticals Inc., a Marlborough drug company owned by Dainippon Sumitomo Pharma Co., of Japan, has received regulatory approval to market its Latuda drug for additional uses in the United States.
Latuda was initially approved by the Food and Drug Administration as a treatment for adults with schizophrenia in 2010. Now the FDA has approved it as a treatment for adults with major depressive episodes associated with bipolar disorder, Sunovion said Wednesday.
The FDA approval allows Latuda to be prescribed as a single drug or as part of a drug cocktail with either Lithium or Valproate.
According to Sunovion, there are few treatments approved for bipolar depression. As a result, the FDA’s approval of Latuda for this condition is a significant event for both patients and the health care providers.
The FDA’s approval for Latuda to treat bipolar disorder requires additional language in the so-called black box warning on the drug’s label for schizophrenia. The black box warning is the agency’s most serious caution. All other medications used for the treatment of bipolar disorder include similar warnings, Sunovion noted.
Sunovion was previously known as Sepracor Inc.