The Medical Letter - 2021
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March 8, 2021 (Issue 1619)
- Sodium Sulfate-Based Tablets (Sutab) for Colonoscopy Preparation
The FDA has approved an oral tablet formulation of sodium sulfate, magnesium sulfate, and potassium chloride (Sutab – Braintree) for colon cleansing prior to colonoscopy in adults. A... - Vericiguat (Verquvo) for Heart Failure
The FDA has approved vericiguat (Verquvo – Merck), an oral soluble guanylate cyclase (sGC) stimulator, to reduce the risk of hospitalization for heart failure and cardiovascular (CV)... - Oliceridine (Olinvyk) - A New Opioid for Severe Pain
Oliceridine (Olinvyk - Trevena), an IV opioid agonist, has been approved by the FDA for management of acute pain severe enough to require an opioid and for which alternative treatment... - Ashwagandha Supplements
Ashwagandha is an herb extracted from the roots of an evergreen shrub (Withania somnifera) found in India that has been used as a "tonic" for centuries. No specific constituent has been... - Comparison Table: Some Drugs for HFrEF (online only)
View the Comparison Table: Some Drugs for HFrEF
February 22, 2021 (Issue 1618)
- Drugs for Parkinson's Disease
The motor symptoms of Parkinson's disease (PD) are caused primarily by degeneration of dopaminergic neurons in the substantia nigra. The nonmotor symptoms of the disease are thought to be caused... - Comparison Table: Drugs for Parkinson's Disease (online only)
View the Comparison Table: Drugs for Parkinson's Disease
February 8, 2021 (Issue 1617)
- Twirla - A New Contraceptive Patch
The FDA has approved Twirla (Agile Therapeutics), a transdermal contraceptive patch containing the estrogen ethinyl estradiol and the progestin levonorgestrel, for use in women with a BMI - Pitolisant (Wakix) for Narcolepsy
The FDA has approved pitolisant (Wakix – Harmony), a histamine-3 (H3)-receptor antagonist/inverse agonist, for treatment of excessive daytime sleepiness (EDS) or cataplexy in... - Osilodrostat (Isturisa) for Cushing's Disease
The FDA has approved osilodrostat (Isturisa – Recordati), a cortisol synthesis inhibitor, for oral treatment of adults with Cushing's disease when surgical resection of the pituitary... - Avapritinib (Ayvakit) for GIST
The FDA has approved the oral tyrosine kinase inhibitor avapritinib (Ayvakit – Blueprint Medicines) for treatment of unresectable or metastatic gastrointestinal stromal tumors (GISTs)...
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....
