Arena Pharma (ARNA) Submits Response to CRL for Lorcaserin NDA; Sees New PDUFA Date
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Arena Pharma (Nasdaq: ARNA) submits its response to the CRL issued by the US FDA following review of the lorcaserin 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 PDUFA date.
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