Posts tagged FDA
FDA Approves Retail Availability of Qsymia Weight Loss Drug
The weight loss drug Qsymia will soon be available at retail pharmacies following approval from the Food and Drug Administration for a change to the distribution options specified in the Risk Evaluation and Mitigation Strategy (REMS). REMS are required by the FDA when drugs are potentially harmful, especially when used in ways other than intended. [...]
Read the full article →EndoBarrier Therapy Gets FDA Approval for Clinical Trials
The FDA has given conditional approval to GI Dynamics to proceed with a pivotal clinical trial of the company’s EndoBarrier Therapy, a new type of treatment for patients with uncontrolled type 2 diabetes and obesity that does not involve medications or surgery. EndoBarrier is a thin, flexible, tube-shaped liner that acts as a physical barrier [...]
Read the full article →FDA Approves Two Medications for Long-Term Weight Control
The Food and Drug Administration (FDA) has approved two new weight loss drugs – marketed as Belviq and Qsymia – within the last 30 days. These are the first medications to be cleared by the FDA for marketing in the United States in 13 years. According to FDA statements, these medications aim “to help obese [...]
Read the full article →5 Points on Safety and Risks of Lap Band Surgery
On December 13, 2011, the U.S. Food and Drug Administration announced that it had issued warning letters to eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, a medical device approved by the FDA for weight loss in obese adults. According to the FDA, the Lap-Band ads used [...]
Read the full article →FDA Rules on Lap-Band Guidelines
The US Food and Drug Administration (FDA) has ruled to lower the body mass index (BMI) requirements for weight loss surgery using the Lap-Band adjustable gastric banding system. This decision confirms the recommendation made by an FDA advisory panel in early December 2010 to lower patient eligibility requirements of lap-band surgery to include people with [...]
Read the full article →Weight Loss Drug Contrave Rejected by FDA
The FDA ruled against approving the weight loss drug Contrave in a decision that surprised many. A positive vote was expected, since an advisory panel had recommended approving the drug by a vote of 13-to-7 in December. As this decision shows, the FDA is not required to follow the advice of its expert panels. Rather, [...]
Read the full article →FDA Panel Votes to Lower BMI Criteria for Lap-Band Surgery
On December 3, 2010, a panel of Food and Drug Administration advisers voted in favor of lowering the body mass index criteria for Lap-Band surgery. If the panel’s recommendation is accepted by the FDA, millions more obese American could qualify for this weight loss procedure. Under current federal guidelines, the Lap-Band is limited to patients [...]
Read the full article →Orexigen Asks FDA for Approval of Contrave Weight Loss Drug
Following successful results in clinical trials with its potential weight loss drug Contrave, Orexigen Therapeutics has taken the next step for market approval and submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). Contrave is now one of several obesity drugs that are currently awaiting FDA approval. Rather than affecting [...]
Read the full article →New Laser Reduces Hunger & Zaps Away Fat
A new low-level laser that zaps away body fat and reduces hunger could have beneficial results for bariatric patients. One of the featured technologies at last weeks Medical Aesthetics Conference was the ZERONA Medical Laser, a non-surgical alternative to liposuction for body-shaping. The ZERONA procedure utilizes a FDA approved cold laser technology that melts away [...]
Read the full article →Gastric Balloon Jump Starts Weight Loss
Allergan Medical has announced that the ORBERA System for weight loss is now available in Canada and Australia. The ORBERA System is a non-surgical and non-pharmaceutical medical device that can help obese and overweight patients lose weight without the risk of surgery or drugs. The ORBERA System, also known as the BIB Intragastric Balloon System, [...]
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