The first generic version of pioglitazone hydrochloride (Actos) was recently approved to improve blood glucose control in adults with type 2 diabetes, along with diet and exercise.
In addition, ranibizumab injection (Lucentis) received FDA approval for a new indication to treat diabetic macular edema. Clinical trials showed 34% to 45% of patients who received monthly injections of 0.3 mg gained at least three lines of vision compared with 12% to 18% of those who did not receive an injection. The most common side effects include bleeding of the conjunctiva, eye pain, floaters and increased intraocular pressure.
Representatives of the FDA also recently explained the reasoning behind their approval of two new drugs (lorcaserin and fixed dose combination of phentermine-topiramate) for chronic weight management in a perspective article in the Oct. 25 New England Journal of Medicine. The representatives explained that both drugs, when combined with both reduced-calorie diets and increased physical activity, met FDA criteria for clinically meaningful weight loss. The FDA is requiring the manufacturers to conduct postapproval clinical trials.