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news.The US Food and Drug Administration (FDA) has accepted Arena Pharmaceuticals' resubmission of the new drug application (NDA) for lorcaserin.
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The FDA considers the resubmission a complete, class 2 response and assigned a new Prescription Drug User Fee Act (PDUFA) target date of 27 June 2012, the company said.
Lorcaserin is intended for weight management in patients who are obese and have at least one weight-related co-morbid condition.
Arena submitted the original NDA for lorcaserin in December 2009 and the FDA issued a complete response letter in October 2010.
The company submitted a response to the lorcaserin CRL in December 2011.
Arena’s wholly owned subsidiary, Arena Pharmaceuticals, has granted Eisai exclusive rights to market and distribute lorcaserin in the US subject to FDA approval of the lorcaserin NDA.