William Weber

All articles by William Weber

Expanded Use for Anti-Diabetes Injection Approved

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company have announced that Byetta (exenatide) injection has been approved for expanded combination therapy in people with type 2 diabetes who have not achieved adequate blood sugar control on a thiazolidinedione (TZD).

New Advisory Issued on MRI Contrast Agents

The FDA has updated a public health advisory it issued last June after receiving reports of 90 patients with moderate to end-stage kidney disease who developed a new condition—nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy (NSF/NFD).

Advisory Issued on Erythropoietin and CKD Patients

In response to a study published in the New England Journal of Medicine (2006;355: 2085-2098) and covered extensively in the lay media, the FDA has issued a public health advisory on the use of erythropoiesis-stimulating agents (ESAs), also known as recombinant human erythropoietin, for treating patients with CKD anemia.

Approvable Letter for Aranesp Extended Dosing

Amgen Inc., of Thousand Oaks, Calif., has received an approvable letter from the FDA for Aranesp (darbepoetin alfa) for de novo once-every-two-week dosing and for once-monthly maintenance dosing for non-dialysis CKD patients with anemia.

Effort to Halt Vendors of Fraudulent Diabetes Cures on Web

As part of an effort by the FDA and the Federal Trade Commission to halt deceptive online advertisements and sales of products misrepresented as diabetes cures or treatments, the agencies have sent approximately 180 letters and advisories to Internet outlets in the United States, Mexico, and Canada.

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