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.
FDA Approves Combination Therapy for Pulmonary Arterial Hypertension
March 25th 2024J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with PAH.