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Cyclosporine Ophthalmic Emulsion (Verkazia) for Vernal Keratoconjunctivitis
The Medical Letter on Drugs and Therapeutics • May 01, 2023 (Issue 1675)
Verkazia (Santen), a 0.1%
ophthalmic emulsion formulation of the calcineurin
inhibitor cyclosporine ...
The FDA has approved Verkazia (Santen), a 0.1%
ophthalmic emulsion formulation of the calcineurin
inhibitor cyclosporine, for treatment of vernal
keratoconjunctivitis (VKC). Verkazia is the first
product to be approved in the US for this indication.
Med Lett Drugs Ther. 2023 May 1;65(1675):70-2 doi:10.58347/tml.2023.1675d | Show Introduction Hide Introduction
Two Vaccines (Arexvy and Abrysvo) for Prevention of RSV Disease
The Medical Letter on Drugs and Therapeutics • Oct 02, 2023 (Issue 1686)
to placebo, for up to 2 RSV
seasons (see Tables 1 and 2).3-5
RSV DISEASE ― RSV typically causes a mild ...
Two recombinant vaccines, Arexvy (GSK) and
Abrysvo (Pfizer), have been approved by the FDA for
prevention of lower respiratory tract disease (LRTD)
caused by respiratory syncytial virus (RSV) in adults
≥60 years old. They are the first RSV vaccines to be
approved in the US. Abrysvo is also approved for
use in pregnant women at 32-36 weeks' gestation
to prevent LRTD caused by RSV in their infants from
birth through 6 months of age.
Med Lett Drugs Ther. 2023 Oct 2;65(1686):155-6 doi:10.58347/tml.2023.1686a | Show Introduction Hide Introduction
In Brief: An Asenapine Patch (Secuado) for Schizophrenia
The Medical Letter on Drugs and Therapeutics • Jan 11, 2021 (Issue 1615)
1). Asenapine was also superior to placebo in
the Clinical Global Impressions-Severity (CGI ...
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. Asenapine is the first antipsychotic
to become available in a transdermal formulation in the US.
A twice-daily sublingual tablet formulation of asenapine
(Saphris) has been available since 2009.
COVID-19 Update: Hypersensitivity Reactions with Tixagevimab/Cilgavimab (Evusheld)
The Medical Letter on Drugs and Therapeutics • Jul 11, 2022 (Issue 1654)
in patients who have experienced a
hypersensitivity reaction to a COVID-19 vaccine.1,2
Evusheld contains ...
The labeling for the investigational, long-acting,
prophylactic anti-SARS-CoV-2 monoclonal antibodies
tixagevimab and cilgavimab (Evusheld; available under
an FDA Emergency Use Authorization) now includes
warnings about a risk of serious hypersensitivity
reactions, including anaphylaxis, with use of the
drugs, particularly in patients who have experienced a
hypersensitivity reaction to a COVID-19 vaccine.
COVID-19 Update: Booster Dose of the Pfizer Vaccine for Children 5-11 Years Old
The Medical Letter on Drugs and Therapeutics • Jun 13, 2022 (Issue 1652)
of the
Pfizer vaccine ≥5 months previously.1
IMMUNOGENICITY – Expansion of the EUA was
based on the results ...
The FDA has expanded its Emergency Use Authorization for the mRNA COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to include administration of a booster dose in children 5-11 years old who completed a primary series of the Pfizer vaccine ≥5 months previously.
In Brief: Over-the-Counter Narcan Nasal Spray
The Medical Letter on Drugs and Therapeutics • May 01, 2023 (Issue 1675)
will be required to
switch them to OTC status and amend their labeling
accordingly.1 Kloxxado, an 8-mg naloxone ...
The FDA has approved the over-the-counter (OTC)
sale of Narcan (Emergent), a nasal spray that delivers
4 mg of the opioid antagonist naloxone. Narcan nasal
spray has been available by prescription since 2015
for emergency treatment of opioid overdose. Generic
formulations of Narcan have also been approved; the
manufacturers of these products will be required to
switch them to OTC status and amend their labeling
accordingly. Kloxxado, an 8-mg naloxone nasal
spray, remains available only by prescription.
Med Lett Drugs Ther. 2023 May 1;65(1675):72 doi:10.58347/tml.2023.1675e | Show Introduction Hide Introduction
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.
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.
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
Intravenous Cetirizine (Quzyttir) for Acute Urticaria
The Medical Letter on Drugs and Therapeutics • Apr 06, 2020 (Issue 1595)
than IV diphenhydramine, but costs much more.
Table 1. Pharmacology
Class Second-generation H1 ...
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...