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.
Anticoagulation Reversal: AndexXa (coagulation factor Xa, recombinant, inactivated-zhzo)
Gastroenteropancreatic Neuroendocrine Tumors: Lutathera (lutetium Lu 177-dota-tate)
Thrombocytopenia in Chronic Immune Thrombocytopenia: Tavalisse (fostamatinib)
Thrombocytopenia in Chronic Liver Disease: Doptelet (avatrombopag)
HIV-1 Infection: Biktarvy (bictegravir/emtricitabine/tenofovir AF)
Lennox-Gastaut Syndrome or Dravet Syndrome Seizures: Epidiolex (cannabidiol)
Reference: U.S. Food and Drug Administration. Novel Drug Approvals for 2018. Accessed June 21, 2018. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/
Medscape © 2018 WebMD, LLC
Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.