FDA Actions in Brief December 2010 (Xgeva, Kombiglyze XR, Egrifta, Baclofen injection, Vyvanse, Halaven, Nexterone, Axiron)

December 1, 2010

Recent FDA Approvals (through November 2010) related to Xgeva, Kombiglyze XR, Egrifta, Baclofen injection, Vyvanse, Halaven, Nexterone, Axiron

Denosumab (Xgeva, Amgen) was approved for the prevention of skeletal-related events in patients with bone metastases from solid tumors.

Saxagliptin, metformin XR (Kombiglyze XR, AstraZeneca and Bristol-Myers Squibb) was approved for the treatment of type 2 diabetes in adults.

Tesamorelin acetate (Egrifta, Theratechnologies and EMD Serono) was approved for the treatment of lipodystrophy in HIV patients.

Lisdexamfetamine dimesylate (Vyvanse, Shire) capsules CII for the treatment of attention deficit hyperactivity disorder in adolescents aged 13 to 17.

Eribulin mesylate (Halaven, Eisai) was approved for the treatment of patients with metastatic breast cancer who have received at least 2 prior chemotherapy regimens for late-stage disease.

Amiodarone HCl (Nexterone, Prism Pharmaceuticals) premixed injection was approved for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. This is the first and only premixed IV bag formulation of the antiarrhythmic agent amiodarone IV.

Testosterone (Axiron, Lilly and Acrux) topical solution CIII was approved for testosterone replacement therapy in men with a deficiency or absence of testosterone.