The September update to the AHFS Drug Information/Essentials database has been published. Highlights from this month’s update include:
New Full-Length Monographs
- Etelcalcetide Hydrochloride (Parsabiv®) – 68:24.04 (Antiparathyroid Agents)
- A calcium-sensing receptor agonist indicated for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
- Obeticholic Acid (Ocaliva®) – 56:92 (GI Drugs, Miscellaneous)
- Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA; [ursodiol per USAN]) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
- Lifitegrast (Xiidra®) – 52:08.92 (Anti-inflammatory Agents, Miscellaneous)
- Treatment of the signs and symptoms of dry eye disease.
New First-Release Monographs
- Sofosbuvir, Velpatasvir, And Voxilaprevir (Vosevi®) – 8:18.40.16 (HCV Polymerase Inhibitors)
- Treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.
- Enasidenib Mesylate (Idhifa®) – 10:00 (Antineoplastic Agents)
- Treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
- Neratinib Maleate (Nerlynx®) – 10:00 (Antineoplastic Agents)
- Extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.
- Glecaprevir And Pibrentasvir (Mavyret®) – 8:18.40.20 (HCV Protease Inhibitors)
- Treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.
FDA MedWatch Alerts