Phentermine is a drug that decreases your appetite.
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.
The Obesity Society (TOS) and the Obesity Action Coalition (OAC) today called on the Food and Drug Administration (FDA) to consider the urgent need for more tools to address the obesity epidemic facing more than 93 million Americans as they convene an advisory panel to review a new treatment for obesity.
VIVUS, Inc. announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for the investigational new drug QNEXA® (phentermine/topiramate) Controlled-Release Capsules. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.
Final verdict on a popular weight loss drug Reductil is to be delivered today. It is being debated whether the pill should be taken off the shelves in Australia and New Zealand. The drug Sibutramine sold as Reductil is linked to increased risk of heart attacks.
VIVUS, Inc. today announced positive top-line results from a two-year study of QNEXA(phentermine/topiramate) Controlled Release Capsules, an investigational therapy for treatment of obesity, a condition that affects approximately one-third of adult Americans.
VIVUS, Inc., a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today reported its financial results for the second quarter and six months ended June 30, 2010.
Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Phentermine Hydrochloride Blue/White Seed Capsules USP, 30 mg, the generic equivalent of Sandoz, Inc.'s Reference Listed Drug (RLD) Phentermine Hydrochloride Capsules USP, 30 mg.
VIVUS, Inc. today announced that data on Qnexa, an investigational drug candidate, will be presented at the Endocrine Society's 92nd Annual Meeting and Expo in San Diego, California. Timothy Garvey, M.D., professor of medicine and chair of the department of nutrition sciences at the University of Alabama at Birmingham and a Qnexa investigator, will deliver an oral presentation at the Clinical Trials Symposium on Saturday, June 19, entitled: "Once-Daily, Low-Dose, Controlled-Release Phentermine/Topiramate Demonstrates Significant Improvement in Weight, Related Risk in Overweight/Obese Patients with Comorbidities."
VIVUS, Inc. today announced that data from a previously reported phase 2 study evaluating the safety and efficacy of the investigational drug Qnexa for the treatment of obstructive sleep apnea were presented at SLEEP 2010, the 24th Annual Meeting of the Associated Professional Sleep Societies.
VIVUS, Inc. today announced the issuance of three additional patents by the U.S. Patent and Trademark Office (USPTO) covering Qnexa, an investigational new drug candidate for the treatment of obesity. The three new patents are the second, third, and fourth patents to be granted in a series of patent applications VIVUS has filed that are directed to the Qnexa product and methods of using Qnexa in various therapeutic applications.
VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's new drug application (NDA) for its investigational drug, Qnexa®, for the treatment of obesity. The target date for the FDA to complete its review of the Qnexa NDA is October 28, 2010.
U.S. Attorney Thomas Scott Woodward announced today that Cardinal Health Pharmacy Services, LLC, a company engaged in providing hospital pharmacy management services, has agreed to pay a civil penalty in the amount of $1 million for failing to account for large amounts of missing prescription drugs.
VIVUS, Inc. today announced positive results from a phase 2 study evaluating the safety and efficacy of Qnexa®, an investigational drug, for the treatment of obstructive sleep apnea (OSA). VIVUS recently completed phase 3 development of Qnexa for the treatment of obesity and submitted a New Drug Application (NDA) to the FDA for that indication.
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VIVUS, Inc., a biopharmaceutical company developing innovative, next-generation medical therapies to address unmet needs in obesity, diabetes and sexual health, announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of Qnexa, its investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.