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www.fdanews.com/articles/100678-j-38-j-submits-nda-for-injectable-invega

J&J Submits NDA for Injectable Invega

November 5, 2007

Johnson & Johnson (J&J) has submitted a new drug application (NDA) for a once-monthly injectable formulation of its atypical antipsychotic Invega.

The NDA is for the treatment and prevention of recurrence of the symptoms of schizophrenia. J&J said the application was sent to the FDA Oct. 25 for standard review, making the estimated FDA action date in late August 2008.

The new formulation is paliperidone palmitate, a long-acting ester of Invega (paliperidone). A trade name for the drug has not been finalized.

The company launched Invega earlier this year. It is a metabolite of Risperdal (risperidone), the firm’s best-selling pharmaceutical product.

Both Risperdal and Risperdal Consta, the injectable formulation of the antipsychotic, had combined sales of $4.18 billion in 2006, according to J&J. Risperdal tablets lose patent protection in June 2008, and the patent for Risperdal Consta expires in 2014.