WASHINGTON (dpa-AFX) - Arena Pharmaceuticals Inc. (ARNA) and Eisai Inc. announced that Arena has submitted its response to the Complete Response Letter or CRL issued by the US Food and Drug Administration following review of the lorcaserin New Drug Application or NDA.
Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition.
The companies expect that later this month the FDA will confirm acceptance of the response and assign a new Prescription Drug User Fee Act (PDUFA) date.
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