Forest Laboratories and Mylan announced that the novel beta blocker Bystolic (nebivolol) was approved by the FDA for the treatment of hypertension.
Genzyme announced that the FDA has approved a supplemental indication for Thyrogen (thyrotropin alfa for injection) to be used in combination with radioiodine to ablate, or destroy, the remaining thyroid tissue in patients who have had their cancerous thyroids removed. Remnant ablation is a procedure that patients commonly undergo when being treated for thyroid cancer.
Novartis informed healthcare professionals of changes made to the warnings, adverse reactions, and dosage and administration sections of prescribing information for Exjade tablets for oral suspension. The labeling was revised to include information about postmarketing reports of hepatic failure, some with a fatal outcome, in patients treated with Exjade. Most of these events occurred in patients greater than 55 years of age. Most reports of hepatic failure involved patients with significant comorbidities, including liver cirrhosis and multi-organ failure.