FDA New Drug and Biologic Approvals, 2018 Midyear Review

In This Issue 

The FDA New Drug and Biologic Approvals, 2018 Midyear Review describes new molecular entities, new biologics, and select new indications by condition for those drugs and biologics approved during the first half of this year. Each summary contains information on the indication, mechanism, dosage, and clinical trials that served as the basis for the FDA approval. For more information, each drug or biologic is linked to its corresponding Medscape drug monograph.

Primary Care

• 高血鉀 Hyperkalemia: Lokelma (sodium zirconium cyclosilicate)
  

• 鴉片戒斷 Opioid Withdrawal: Lucemyra (lofexidine)
  

• 斑塊性乾癬 Plaque Psoriasis: Ilumya (tildrakizumab)

• 類風濕性關節炎 Rheumatoid Arthritis: Olumiant (baricitinib)
  

• New Indications

Hematology/Oncology

• 反轉抗凝血因子 Anticoagulation Reversal: AndexXa (coagulation factor Xa, recombinant, inactivated-zhzo)
  

• 成人胃腸胰腺神經內分泌腫瘤 Gastroenteropancreatic Neuroendocrine Tumors: Lutathera (lutetium Lu 177-dota-tate)
  

• 苯酮尿症 Phenylketonuria: Palynziq (pegvaliase)
  

• 前列腺癌 Prostate Cancer: Erleada (apalutamide)
  

• 血小板低下 Thrombocytopenia in Chronic Immune Thrombocytopenia: Tavalisse (fostamatinib)
  

• Thrombocytopenia in Chronic Liver Disease: Doptelet (avatrombopag)
  

• 黑色素細胞癌 Unresectable or Metastatic Melanoma: Mektovi (binimetinib)
  

• Unresectable or Metastatic Melanoma: Braftovi (encorafenib)
  

• New Indications/Other Oncology Updates

Infectious Disease

• HIV-1 Infection: Biktarvy (bictegravir/emtricitabine/tenofovir AF)
  

• HIV-1 Infection: Trogarzo (ibalizumab)
  

• 蟠尾絲蟲症 Onchocerciasis: Moxidectin

• 泌尿道感染 Urinary Tract Infection: Zemdri (plazomicin)
  

• New Indications

Neurology

• 雷葛氏症候群 爪費症候群 Lennox-Gastaut Syndrome or Dravet Syndrome Seizures: Epidiolex (cannabidiol)
  

• 偏頭痛 Migraine: Aimovig (erenumab)
  

• New Indications

Pediatrics

• 囊狀纖維化 Cystic Fibrosis: Symdeko (tezacaftor/ivacaftor)
  

• 佝僂病 Rickets: Crysvita (burosumab)
  

• New Indications