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FDA Authorizes Johnson & Johnson COVID-19 Vaccine

   
The Medical Letter on Drugs and Therapeutics • Mar 22, 2021  (Issue 1620)
received EUAs in December 2020.1,2 CLINICAL STUDIES — Issuance of the EUA was based on the results ...
On February 27, 2021, the FDA issued an Emergency Use Authorization (EUA) for the Johnson & Johnson adenovirus-based vaccine for prevention of COVID-19 in persons ≥18 years old. It is the third COVID-19 vaccine to become available in the US and the first to require only a single dose. Two-dose mRNA-based vaccines manufactured by Pfizer-BioNTech and Moderna received EUAs in December 2020.
Med Lett Drugs Ther. 2021 Mar 22;63(1620):41-2 | Show Introduction Hide Introduction

Expanded Table: Some Vaccines for Travelers (online only)

   
The Medical Letter on Drugs and Therapeutics • Nov 19, 2018  (Issue 1560)
with chloroquine Hepatitis A (HepA) Havrix (GSK) Vaqta (Merck) 1 mL IM (1440 EL.U) 1 mL IM (50 units) 1-18 ...
View the Expanded Table: Some Vaccines for Travelers
Med Lett Drugs Ther. 2018 Nov 19;60(1560):e192-4 | Show Introduction Hide Introduction

Fenfluramine (Fintepla) for Dravet Syndrome

   
The Medical Letter on Drugs and Therapeutics • Aug 09, 2021  (Issue 1630)
Results Reduction in Seizure Frequency Responder Regimen1 vs Placebo2 Rate3 Study 1 (14 weeks; n=119)4 ...
The FDA has approved fenfluramine oral solution (Fintepla – Zogenix) for treatment of seizures in patients ≥2 years old with Dravet syndrome. It is the third drug to be approved for this indication. Stiripentol (Diacomit) and cannabidiol (Epidiolex), a purified product derived from marijuana, were approved earlier.
Med Lett Drugs Ther. 2021 Aug 9;63(1630):126-8 | Show Introduction Hide Introduction

In Brief: Avelumab (Bavencio) for Metastatic Merkel Cell Carcinoma (online only)

   
The Medical Letter on Drugs and Therapeutics • Jul 17, 2017  (Issue 1525)
-human programmed death ligand 1 (PD-L1) blocking antibody avelumab (Bavencio – EMD Serono/Pfizer ...
The FDA has approved the fully-human programmed death ligand 1 (PD-L1) blocking antibody avelumab (Bavencio – EMD Serono/Pfizer) for treatment of metastatic Merkel cell carcinoma (MCC) in patients ≥12 years old. Avelumab is the first drug to be approved in the US for this rare skin cancer. About 1600 people in the US, most commonly older adults (mean age at presentation is 75 years), are diagnosed each year with MCC. Most of these patients can be treated with surgical resection, but ~50% will have a recurrence and >30% will eventually have metastatic disease. Median progression-free...
Med Lett Drugs Ther. 2017 Jul 17;59(1525):e120 | Show Introduction Hide Introduction

Minocycline Foam (Amzeeq) for Acne

   
The Medical Letter on Drugs and Therapeutics • May 04, 2020  (Issue 1597)
tetracycline is recommended because of its dual antibacterial and anti-inflammatory activity.1,2 Monotherapy ...
The FDA has approved a 4% aerosol foam formulation of minocycline (Amzeeq – Foamix) for topical treatment of inflammatory lesions of non-nodular moderate to severe acne in patients ≥9 years old. It is the first topical tetracycline formulation to be approved for use in patients with acne. Oral minocycline (Minocin, Solodyn, and generics) is
Med Lett Drugs Ther. 2020 May 4;62(1597):68-70 | Show Introduction Hide Introduction

OTC Drugs for Seasonal Allergies

   
The Medical Letter on Drugs and Therapeutics • Apr 22, 2019  (Issue 1570)
of allergic rhinitis and allergic conjunctivitis are reviewed separately.1 INTRANASAL CORTICOSTEROIDS ...
Patients with seasonal allergies often experience nasal itching and congestion, sneezing, rhinorrhea, and itchy, watery eyes. Oral, intranasal, and ophthalmic preparations are widely available over the counter (OTC) for relief of symptoms. Prescription products for management of allergic rhinitis and allergic conjunctivitis are reviewed separately.
Med Lett Drugs Ther. 2019 Apr 22;61(1570):57-60 | Show Introduction Hide Introduction

Intravenous Cetirizine (Quzyttir) for Acute Urticaria

   
The Medical Letter on Drugs and Therapeutics • Apr 06, 2020  (Issue 1595)
diphenhydramine, but costs much more. Table 1. Pharmacology Class Second-generation H1-antihistamine ...
Quzyttir (TerSera), an IV formulation of the second-generation H1-antihistamine cetirizine, has been approved by the FDA for treatment of acute urticaria in patients ≥6 months old. Oral formulations of cetirizine (Zyrtec, and others) have been for sale over the counter for years. Quzyttir is the first parenteral formulation of a second-generation H1-antihistamine to become available in the US; parenteral formulations of two first-generation H1-antihistamines, diphenhydramine (Benadryl, and others) and hydroxyzine (Vistaril, and others), have been available for many...
Med Lett Drugs Ther. 2020 Apr 6;62(1595):55-6 | Show Introduction Hide Introduction

Risankizumab (Skyrizi) for Psoriasis

   
The Medical Letter on Drugs and Therapeutics • Jun 03, 2019  (Issue 1573)
. The first year of treatment costs $88,500. Its long-term safety is unknown. Table 1. Pharmacology Class ...
The FDA has approved the interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) for treatment of moderate to severe plaque psoriasis in adults. Risankizumab is the third IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) and tildrakizumab (Ilumya) were approved earlier.
Med Lett Drugs Ther. 2019 Jun 3;61(1573):81-3 | Show Introduction Hide Introduction

Anifrolumab (Saphnelo) for Systemic Lupus Erythematosus

   
The Medical Letter on Drugs and Therapeutics • Sep 20, 2021  (Issue 1633)
of anifrolumab was based on the results of three 52-week, double-blind trials (MUSE, TULIP-1, and TULIP-2 ...
The FDA has approved anifrolumab-fnia (Saphnelo – AstraZeneca), a type I interferon receptor antagonist, for IV treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard treatment. Anifrolumab has not been studied in patients with severe active lupus nephritis or severe active CNS lupus. It is the first type I interferon receptor antagonist to become available in the US.
Med Lett Drugs Ther. 2021 Sep 20;63(1633):146-7 | Show Introduction Hide Introduction

Meropenem/Vaborbactam (Vabomere) for Complicated Urinary Tract Infection

   
The Medical Letter on Drugs and Therapeutics • Jun 18, 2018  (Issue 1549)
Vabomere: vay' boh mere Vaborbactam: vab" or bak' tam Table 1. Pharmacology Class Carbapenem/beta ...
The FDA has approved a fixed-dose combination of meropenem, a carbapenem antibiotic, and vaborbactam, a new beta-lactamase inhibitor (Vabomere – Melinta), for IV treatment of adults with complicated urinary tract infections (UTIs) that are proven or strongly suspected to be caused by Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae spp. complex. Meropenem (Merrem, and generics) has been approved for years for treatment of complicated skin and skin structure infections, intra-abdominal infections, and bacterial meningitis. Resistance to meropenem and other...
Med Lett Drugs Ther. 2018 Jun 18;60(1549):103-5 | Show Introduction Hide Introduction