VIVUS

FDA approves Stendra for ED

Monday, April 30, 2012 03:45 PM

The FDA has approved Stendra (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S., according to biopharmaceutical company Vivus.

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FDA advisory committee recommends Qnexa for approval

Monday, February 27, 2012 10:03 AM

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has recommended Vivus’ adult obesity drug Qnexa be granted marketing approval by the FDA.

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FDA reviews NDA for VIVUS' Qnexa

Tuesday, December 27, 2011 11:11 AM

VIVUS has reported that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012. VIVUS resubmitted the NDA on seeking approval to market Qnexa in the United States. The FDA has accepted the NDA for review. The target date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.

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VIVUS resubmits NDA for Qnexa

Monday, October 17, 2011 11:37 AM

VIVUS has resubmitted the New Drug Application (NDA) for Qnexa to the FDA. The resubmission follows an agreement reached in September 2011 with officials of the endocrine and metabolic division of the FDA on the filing strategy for Qnexa. The NDA resubmission seeks approval for an initial indication for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients or overweight patients with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling for Qnexa includes a contraindication for women of childbearing potential.  The NDA resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).

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VIVUS to re-submit QNEXA NDA

Thursday, September 15, 2011 12:21 PM

VIVUS has reached agreement with officials of the Endocrine and Metabolic Division of the FDA on a plan that allows for an early resubmission of the QNEXA New Drug Application for the treatment of obesity. The resubmission plan allows VIVUS to seek approval for an initial indication that includes obese men and women of non-child bearing potential.  Based on this agreement, VIVUS intends to resubmit the QNEXA NDA by the end of October 2011, prior to completion of the FORTRESS study.

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VIVUS Submits NDA for Treatment of Erectile Dysfunction

Friday, July 1, 2011 10:20 AM

VIVUS has submitted a New Drug Application (NDA) to the FDA seeking approval of avanafil, its investigational drug for the treatment of erectile dysfunction (ED). The NDA submission follows the successful completion of an extensive phase III program for avanafil, which included over 1,350 patients, where avanafil was shown to be well tolerated and effective in treating men with ED.

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