Orchid Pharma gets USFDA nod for schizophrenia drug
New Delhi: Orchid Pharma said it has received approval from the US health regulator for Aripiprazole Orally-Disintegrating tablets, used in the treatment of schizophrenia and bipolar disorder.
In a filing to BSE, the company said it "has received ANDA (abbreviated new drug application) approval from USFDA (United States Food and Drug Administration) for Aripiprazole Orally-Disintegrating tablets USP, 10 mg and 15 mg."
The tablets are atypical antipsychotic, indicated in the treatment of symptoms related to psychotic conditions such as schizophrenia and bipolar disorder (manic depression), it added.
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