FDA Actions in Brief October 2011 (Remicade, Prolia, haloperidol injection, Soliris)

October 1, 2011

Recent FDA Approvals (through September 2011) related to Remicade, Prolia, haloperidol injection, Soliris

Infliximab (Remicade, Janssen Biotech) was approved for the treatment of moderately to severely active ulcerative colitis in pediatric patients older than 6 years who have had an inadequate response to conventional therapy.

Two new indications for denosumab (Prolia, Amgen) were approved. Prolia has been approved as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer, and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer. Prolia is the first-and-only therapy approved by FDA for cancer treatment-induced bone loss in patients undergoing hormone ablation therapy.

Haloperidol injection USP (Sagent) antipsychotic in 5 mg per mL single-dose and 50 mg per 10 mL multi-dose, latex-free vials was approved for the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette's disorder.