Phentermine is a drug that decreases your appetite.
Arena Pharmaceuticals, Inc. announced today that Eisai Limited (based in Mississauga, Ontario), a subsidiary of Eisai Inc., has submitted a New Drug Submission for BELVIQ (lorcaserin HCl) with Health Canada.
VIVUS, Inc. announced today that a new study demonstrates that effective medical treatment providing 10% to 15% weight loss could lead to significant improvements in Medicare spending by reversing or reducing significant health consequences such as type 2 diabetes, hypertension and dyslipidemia in obese or overweight patients.
ScinoPharm announced today that its Tainan, Taiwan Facility will provide commercial manufacturing of topiramate active pharmaceutical ingredient ("API") for VIVUS' Qsymia, a new drug for the treatment of obesity approved by the United States Food and Drug Administration on July 17, 2012.
The U.S. Food and Drug Administration today approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management.
Post-hoc analysis of randomized trial results shows that treating individuals with Type 2 diabetes with a combination of phentermine and topiramate increases their achievement of goals recommended for the management of their condition.
An experimental drug helped significantly more overweight patients with diabetes shed pounds, compared with placebo, a new study finds. The results will be presented Saturday at The Endocrine Society's 94th Annual Meeting in Houston.
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.