FDA Accepts Arena's NDA Resubmission for Lorcaserin
The FDA considers the resubmission a complete, class 2 response, and assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012.
Arena Pharmaceuticals, Inc. and Eisai Inc. announced yesterday that the US FDA has accepted for filing and review Arena's resubmission of the New Drug Application (NDA) for lorcaserin.
Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese or patients who are overweight and have at least one weight-related co-morbid condition.
The FDA considers the resubmission a complete, class 2 response, and assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012.
Arena submitted the original NDA for lorcaserin in December 2009, and the FDA issued a
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