Phentermine is a drug that decreases your appetite.
The drug was rejected in a 10-6 vote the first time it came before a Food and Drug Administration (FDA) advisory panel, in 2010, due to safety concerns. However when the medication returned for another review in February, the advisory committee gave it near-unanimous approval (20-2). Because the FDA often follows the advisory panel's advice, Qnexa is likely to get FDA approval, probably by mid-April.
Qnexa took a step closer to approval on Wednesday, when outside advisers to the U.S. Food and Drug Administration voted 20-to-2 in favor of approval. The panel also recommended the company conduct a study to scrutinize even more closely any risk of heart problems. That study may be required after the drug is approved. Should the FDA ask for further data on heart risks before any approval, it would delay Qnexa's launch further.
VIVUS, Inc. today announced that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults.
The weight loss pill Qnexa has been once rejected by the FDA over safety concerns. But this Wednesday it will get a second chance before an FDA advisory committee. Qnexa maker Vivus Inc. hopes something might come out of this second chance. The company will be submitting new safety data from patients who took Qnexa for a second year after completing a one-year clinical trial.
Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its supplemental Abbreviated New Drug Application (ANDA) for Phentermine HCl Capsules, 15 mg.
VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012.
VIVUS, Inc. today announced that results from the SEQUEL study were published in The American Journal of Clinical Nutrition, a peer-reviewed journal with broad, multidisciplinary readership.
VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the New Drug Application (NDA) for Qnexa to treat obesity. The company resubmitted the NDA on October 17, 2011.
VIVUS, Inc. today announced that multiple abstracts were presented at the 47th European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon, Portugal. The presentations highlighted the long-term beneficial effects of QNEXA treatment in metabolically-impaired patients with prediabetes, diabetes, and metabolic syndrome.
VIVUS, Inc. today announced that additional data from the phase 3 QNEXA studies will be presented today during the American Association of Diabetes Educators (AADE) meeting in Las Vegas, NV.
Lannett Company, Inc. today announced the U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for Phentermine Resin Extended-Release Capsules, 15 mg and 30 mg, representing the fourth product approval the company has received in the last five weeks.
VIVUS, Inc. today announced that on August 31, 2011, during the late breaking poster session at the 29th International Epilepsy Congress in Rome, Italy, Dr. Alison Pack, Associate Professor of Clinical Neurology, Department of Neurology, Columbia University Medical Center, will present the results of a retrospective study of medical claims data on oral clefts (OC) and major congenital malformations (MCMs) associated with in utero topiramate exposure.
VIVUS, Inc. today announced that multiple abstracts have been accepted for presentation at the upcoming American Diabetes Association (ADA) meeting to be held June 24th to June 28th, 2011, at the San Diego Convention Center, San Diego, CA.
VIVUS, Inc. today announced that detailed results from the 56-week CONQUER study were published in The Lancet evaluating the efficacy and safety of investigational drug QNEXA in 2,487 patients across 93 sites in the US.
An investigational combination of drugs already approved to treat obesity, migraine and epilepsy produced up to a 10 percent weight loss in obese individuals participating in a one-year clinical trial, according to researchers at Duke University Medical Center.
According to the latest research on obesity treatments there is now a new weapon in the battle for weight loss. It combines two existing drugs that have resulted in twice as much weight loss as the only approved long-term anti-obesity medication.
Elite Pharmaceuticals, Inc. announced today the approval of an Abbreviated New Drug Application for phentermine HCl 37.5 mg tablets by the U.S. Food and Drug Administration. The phentermine HCl tablets are the generic equivalent of the Adipex-P 37.5 mg tablets.
VIVUS, Inc. today announced that it held an End-of-Review meeting with the Food and Drug Administration (FDA) for the New Drug Application (NDA) for QNEXA®, an investigational drug for the treatment of obesity. The meeting occurred on January 19th at the FDA's offices in Maryland and was attended by senior members of the FDA and VIVUS' management and consultants.
VIVUS, Inc. today announced that the company filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for QNEXA® (phentermine/topiramate) Controlled Release Capsules in the European Union (EU). The proposed indication in the EU is for the treatment of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a mildly hypocaloric diet.
VIVUS, Inc. today announced that the company, as part of its continuing effort to secure regulatory approval for QNEXA® in the U.S., submitted a briefing document to the Food and Drug Administration (FDA) designed to address items in the FDA's Complete Response Letter (CRL), issued on October 28, 2010. The company also announced that the Endocrine and Metabolic Division of the FDA has granted VIVUS a meeting in the second half of January 2011 to discuss the content of the proposed resubmission.