2 IN. DI LETTURA
* FDA approves schizophrenia drug
* Label to include boxed warning
* Shares jump 8 fold in after-hours trade
May 6 (Reuters) - Embattled drug-maker Vanda Pharmaceuticals Inc (VNDA.O) said U.S. health regulators approved its treatment for schizophrenia, triggering an eight-fold rise in its shares.
The U.S. Food and Drug Administration said label for the drug Fanapta, or iloperidone, will include a boxed warning, just like other atypical antipsychotic class of drugs.
The FDA said the warning will advise doctors and patients about increased risk of death, if the drug is used off-label for behavioral problems in older people with dementia-related psychosis.
The FDA had issued a not-approvable letter in October over concerns of efficacy of the atypical antipsychotic drug in comparison with Johnson & Johnson's (JNJ.N) risperidone in patients suffering from schizophrenia.
Shares of the Rockville, Maryland-based company surged to to $8.00, after the bell. They closed at $1.08 Wednesday, on Nasdaq. (Reporting by Vidya L Nathan in Bangalore; Editing by Anil D'Silva)