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news.Breckenridge Pharmaceutical has signed an agreement with Ajanta Pharma to market its abbreviated new drug application for Risperidone Tablets, the generic version of Janssen Pharma's Risperdal tablets.
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Pursuant to the agreement, Ajanta Pharma will manufacture and supply Risperidone Tablets to Breckenridge, who will have exclusive marketing and distribution rights in the US.
The product is available in six strengths 0.25mg, 0.5mg, 1mg, 2mg, 3mg and 4mg and companies expect to begin the shipment immediately.
Risperidone tablets, an atypical antipsychotic agents, are indicated for the treatment of schizophrenia in adults and adolescent aged 13-17 years alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescent aged 10-17 years, and also for the treatment of irritability associated with autistic disorder in children and adolescents aged five-16 years.