US FDA delays extending label for Janssen’s Invega Sustenna

The US Food and Drug Administration issued a Complete Response letter regarding the supplemental New Drug Application for once-monthly long-acting antipsychotic Invega Sustenna (paliperidone palmitate) filed by Janssen Pharmaceuticals, a unit of US health care giant Johnson & Johnson (NYSE: JNJ).

The sNDA seeks to expand the product's label to include data showing that treatment with Invega Sustenna is effective six months longer than commonly prescribed oral antipsychotics in people with schizophrenia.

Invega Sustenna was approved by the FDA in July 2009 as the first once-monthly atypical long-acting injectable antipsychotic to treat schizophrenia and is now approved in more than 80 countries. First-quarter 2015 sales of the drug were up 10.2% to $411 million.