New Drug Approvals Archive - February 2017
Xyzal (levocetirizine dihydrochloride)
New Dosage Form Approved: January 31, 2017
New Indication Approved: February 2, 2017
- Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma
Read more: Opdivo (nivolumab) FDA Approval History
Parsabiv (etelcalcetide) Injection
Date of Approval: February 7, 2017
Company: Amgen Inc.
Treatment for: Secondary Hyperparathyroidism
Parsabiv (etelcalcetide) is a calcium-sensing receptor agonist indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
- FDA Approves Amgen's Parsabiv (etelcalcetide) for Secondary Hyperparathyroidism in Adult Patients on Hemodialysis
Emflaza (deflazacort) Tablets and Oral Suspension
Date of Approval: February 9, 2017
Company: PTC Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy
Emflaza (deflazacort) is a glucocorticoid for the treatment of Duchenne Muscular Dystrophy.
Read more: Emflaza (deflazacort) FDA Approval History
Siliq (brodalumab) Injection
Date of Approval: February 15, 2017
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Plaque Psoriasis
Siliq (brodalumab) is a human anti-interleukin-17-receptor monoclonal antibody for the treatment of plaque psoriasis.
Read more: Siliq (brodalumab) FDA Approval History
Spiriva Respimat (tiotropium bromide)
Patient Population Altered: February 15, 2017
- FDA Expands Approval of Spiriva Respimat (tiotropium bromide) Inhalation Spray for Maintenance Treatment of Asthma in Children
New Indication Approved: February 22, 2017
- FDA Expands Indication for Revlimid (lenalidomide) as a Maintenance Treatment for Patients with Multiple Myeloma Following Autologous Hematopoietic Stem Cell Transplant (auto-HSCT)
Read more: Revlimid (lenalidomide) FDA Approval History
Qtern (dapagliflozin and saxagliptin) Tablets
Date of Approval: February 27, 2017
Treatment for: Diabetes Type 2
Qtern (dapagliflozin and saxagliptin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor fixed-dose combination for the treatment of adult patients with type 2 diabetes.
- FDA Approves Once-Daily Qtern (dapagliflozin and saxagliptin) Tablets for Adults with Type-2 Diabetes
Xermelo (telotristat ethyl) Tablets
Date of Approval: February 28, 2017
Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Carcinoid Syndrome Diarrhea
Xermelo (telotristat ethyl) is an oral tryptophan hydroxylase inhibitor indicated for use in combination with somatostatin analog (SSA) therapy for the treatment of carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors.
- FDA Approves Xermelo (telotristat ethyl) as First and Only Oral Treatment for Carcinoid Syndrome Diarrhea in Cancer Patients with Metastatic Neuroendocrine Tumors