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VIVUS announces additional data from phase 3 QNEXA studies on obesity

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.

6 Aug 2011

FDA approves Lannett's ANDA for Phentermine Resin Extended-Release Capsules

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.

29 Jul 2011

VIVUS to present topiramate exposure, birth defect data at IEC

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.

20 Jul 2011

Multiple abstracts on QNEXA long-term clinical study to be presented at ADA 2011

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.

22 Jun 2011

The Lancet publishes VIVUS 56-week QNEXA study results in obesity

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.

11 Apr 2011

Investigational drug effective for patients with obesity

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.

11 Apr 2011

New weight loss pill - combination of two existing drugs

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.

10 Apr 2011

FDA approves ANDA for phentermine HCl 37.5 mg tablets

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.

4 Feb 2011

VIVUS holds End-of-Review meeting with FDA for QNEXA NDA

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.

21 Jan 2011

VIVUS seeks marketing approval of QNEXA in the EU

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.

20 Dec 2010

VIVUS submits briefing document to FDA in effort to secure regulatory approval for QNEXA

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.

14 Dec 2010

TOS, OAC call on FDA to address urgent need for obesity treatments

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.

8 Dec 2010

VIVUS receives FDA CRL for QNEXA NDA

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.

29 Oct 2010

Weight loss pill off shelves due to heart attack risk

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.

10 Oct 2010

VIVUS announces QNEXA study results for obesity treatment

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.

21 Sep 2010

VIVUS second-quarter total revenue decreases to $3.9 million

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.

3 Aug 2010

Lannett's ANDA for Phentermine Hydrochloride Blue/White Seed Capsules receives FDA approval

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.

21 Jul 2010

VIVUS to present data on Qnexa at ENDO meeting

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."

16 Jun 2010

Phase 2 study results of Qnexa in patients with OSA presented at SLEEP 2010

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.

8 Jun 2010

VIVUS granted three additional patents for Qnexa

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.

8 Mar 2010