The FDA has approved Sanofi-Aventis' Amaryl (glimepiride) Tablets as an adjunct to diet and exercise to lower blood glucose in patients with noninsulin-dependent (type 2) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone. Amaryl is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent.
Wyeth announced that the FDA has approved Effexor XR (venlafaxine HCl) for the treatment of adults with panic disorder. This marks the first antidepressant approved for panic disorder since 2002, the firm said.
The FDA has approved a new, higher dose formulation of Shire's Fosrenol (lanthanum carbonate). The new, higher dose strengths of 750 milligrams and 1.0 gram will be available in the U.S. by year-end. This formulation will help reduce the number of pills end-stage renal disease (ESRD) patients must take to achieve target phosphorus levels, thereby helping to simplify the treatment of hyperphosphatemia.
Abbott announced the FDA's approval of a new indication for Depakote ER (divalproex sodium extended-release tablets) for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.