WASHINGTON (dpa-AFX) - Arena Pharmaceuticals, Inc. (ARNA) and Eisai Inc. said the FDA has accepted for filing and review Arena's resubmission of the New Drug Application, or NDA, for lorcaserin. The FDA considers the resubmission a complete, class 2 response, and assigned a new Prescription Drug User Fee Act target date of June 27, 2012.
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.
Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States subject to FDA approval of the lorcaserin NDA.
Copyright RTT News/dpa-AFX
© 2012 AFX News
