Posts Tagged ‘FDA’

November 29, 2012 — The recent approval of two new obesity medications was good news for patients with obesity, but scant health insurance reimbursement of the products has limited physician prescribing and patient use. The news that Aetna, the third largest U.S. insurer, will provide coverage for these drugs marks another important step forward.

November 17, 2012 — A proposal from FDA for an expansive approach to OTC drugs spurred the American College of Allergy, Asthma, and Immunology (ACAAI) to hold a symposium on the subject and to hotly debate the topic throughout the course of its annual meeting this week.

October 19, 2012 — An article in today’s Financial Times pointed out that though Lorcaserin (to be marketed as Belviq) is expected to receive Schedule IV status from the US Drug Enforcement Agency or DEA (the FDA recommended Schedule IV, and the DEA tends to follow the direction of the FDA), experts and healthcare advocates don’t […]

October 11, 2012 — In a major breakthrough for people looking for new and effective treatments for obesity, Bloomberg/Business Week reports that the FDA is considering a pathway that would allow drugs like those for obesity or life-saving antibiotics that are deemed to offer societal benefit despite their risks to get speedier approval, according to […]

October 3, 2012 — Qsymia is the first new prescription weight loss medication on the market in over 10 years, and many, including the innovator company Vivus, thought that this new medication would not be reimbursed by health plans. Payers and many experts were surprised then, by the news that Qsymia was covered by health […]

August 14, 2012 — Today, the George Washington University School of Public Health held a live panel discussion to talk about the just-released consensus report developed by a range of obesity experts in the last nine months to help guide the FDA when evaluating the benefits and risks of potential new obesity drugs. Until this […]

July 18, 2012 — After more than a decade of denying approval for every prescription obesity treatment that came to them for review, the FDA has approved the second new product in less than a month. Qsymia, formerly known as QNEXA, is a controlled-release formulation of two drugs already approved for other uses, phentermine and […]

June 27, 2012 — The Food and Drug Administration announced its approval of lorcaserin today, paving the way for the drug to become only the second prescription obesity treatment available to the roughly one-third of American who have the condition. 

In an 18-4 decision with one abstention, a panel of experts voted to approve the first new obesity drug in over a decade. Lorcaserin, made by Arena Pharmaceuticals, was voted down when it came before the FDA in 2010 because of certain safety risks and a feeling the drug was not effective enough in helping […]

March 29, 21012 — A panel of experts at the FDA voted 17-6 in favor of requiring all new obesity drugs seeking approval to provide phase 2 or 3 safety data ruling out excess cardiovascular risk, even if the drug does not appear to have a cardiovascular profile.