• Drug Coverage
  • Hypertrophic Cardiomyopathy (HCM)
  • Vaccines: 2023 Year in Review
  • Eyecare
  • Urothelial Carcinoma
  • Women's Health
  • Hemophilia
  • Heart Failure
  • Vaccines
  • Neonatal Care
  • NSCLC
  • Type II Inflammation
  • Substance Use Disorder
  • Gene Therapy
  • Lung Cancer
  • Spinal Muscular Atrophy
  • HIV
  • Post-Acute Care
  • Liver Disease
  • Pulmonary Arterial Hypertension
  • Safety & Recalls
  • Biologics
  • Asthma
  • Atrial Fibrillation
  • Type I Diabetes
  • RSV
  • COVID-19
  • Cardiovascular Diseases
  • Breast Cancer
  • Prescription Digital Therapeutics
  • Reproductive Health
  • The Improving Patient Access Podcast
  • Blood Cancer
  • Ulcerative Colitis
  • Respiratory Conditions
  • Multiple Sclerosis
  • Digital Health
  • Population Health
  • Sleep Disorders
  • Biosimilars
  • Plaque Psoriasis
  • Leukemia and Lymphoma
  • Oncology
  • Pediatrics
  • Urology
  • Obstetrics-Gynecology & Women's Health
  • Opioids
  • Solid Tumors
  • Autoimmune Diseases
  • Dermatology
  • Diabetes
  • Mental Health

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

News
Article

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.

Related Videos
Related Content
© 2024 MJH Life Sciences

All rights reserved.