The Medical Letter - 2021
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January 25, 2021 (Issue 1616)
- FDA Authorizes Moderna COVID-19 Vaccine
On December 18, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Moderna mRNA-based vaccine for prevention of COVID-19 in persons ≥18 years old. The Pfizer-BioNTech... - Antibacterial Drugs for Community-Acquired Pneumonia
Treatment of community-acquired pneumonia (CAP) is usually empiric, with selected antibiotic regimens directed against some of the most common causative pathogens. Recommended empiric regimens... - In Brief: Semglee - A New Insulin Glargine for Diabetes
The FDA has approved Semglee (Mylan), an insulin glargine product similar to Lantus, for treatment of type 1 diabetes in children and adults and type 2 diabetes in adults.... - Encorafenib (Braftovi) for Metastatic Colorectal Cancer
The FDA has approved the oral kinase inhibitor encorafenib (Braftovi – Pfizer), in combination with the epidermal growth factor receptor (EGFR) inhibitor cetuximab (Erbitux), for...
January 11, 2021 (Issue 1615)
- FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine
The FDA has issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech mRNA-based vaccine for prevention of COVID-19 in persons ≥16 years old. - Baloxavir (Xofluza) for Post-Exposure Prophylaxis of Influenza
The oral polymerase acidic endonuclease inhibitor baloxavir marboxil (Xofluza — Genentech) is now FDAapproved for post-exposure prophylaxis of influenza in patients ≥12 years old.... - Opicapone (Ongentys) - A COMT Inhibitor for Parkinson's Disease
The FDA has approved opicapone (Ongentys – Neurocrine), a peripherally-acting reversible catechol-O-methyltransferase (COMT) inhibitor, for oral use as an adjunct to carbidopa/levodopa in... - Metoclopramide Nasal Spray (Gimoti) for Diabetic Gastroparesis
The FDA has approved Gimoti (Evoke), a nasal spray formulation of the dopamine-2 (D2) receptor antagonist metoclopramide, for relief of symptoms in adults with acute and... - In Brief: An Asenapine Patch (Secuado) for Schizophrenia
A transdermal formulation of the second-generation (atypical) antipsychotic asenapine (Secuado – Noven) has been approved by the FDA for once-daily treatment of schizophrenia in adults....
