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Lefamulin (Xenleta) for Community-Acquired Bacterial Pneumonia
The Medical Letter on Drugs and Therapeutics • Sep 23, 2019 (Issue 1581)
to be approved in the
US; retapamulin (Altabax), a 1% topical ointment for
treatment of impetigo, was approved ...
Lefamulin (Xenleta – Nabriva), a semisynthetic
pleuromutilin antibiotic, has been approved by the
FDA for IV and oral treatment of community-acquired
bacterial pneumonia (CABP) in adults. It is the first
systemic pleuromutilin antibiotic to be approved in the
US; retapamulin (Altabax), a 1% topical ointment for
treatment of impetigo, was approved in 2007.
In Brief: Ezallor Sprinkle - A New Formulation of Rosuvastatin
The Medical Letter on Drugs and Therapeutics • Sep 23, 2019 (Issue 1581)
tablets (Crestor, and generics)
have been available since 2003.1,2
Table 1: Rosuvastatin Products
Drug ...
The lipid-lowering drug rosuvastatin is now available in a sprinkle capsule formulation (Ezallor Sprinkle – Sun Pharma). Rosuvastatin tablets (Crestor, and generics) have been available since 2003.1,2The new formulation is being marketed specifically for residents of long-term care facilities who have difficulty swallowing. Ezallor Sprinkle capsules can be swallowed whole or opened and their contents sprinkled over applesauce or mixed with water for administration via nasogastric tube.For those long-term care residents who still have a reasonable indication for a statin but have difficulty...
Altuviiio – A Longer-Acting Factor VIII Product for Hemophilia A
The Medical Letter on Drugs and Therapeutics • May 01, 2023 (Issue 1675)
of Altuviiio
was based on the results of two prospective, open-label
trials (XTEND-1 [published] and XTEND ...
The FDA has approved Altuviiio (Sanofi), a von
Willebrand Factor (VWF)-independent, recombinant
factor VIII concentrate, for routine prophylaxis, on-demand
treatment to control bleeding episodes, and
perioperative management of bleeding in children and
adults with hemophilia A. The manufacturer claims that
Altuviiio, which was previously called efanesoctocog
alfa, delivers normal to near-normal factor VIII levels for
most of the week with once-weekly intravenous dosing.
Med Lett Drugs Ther. 2023 May 1;65(1675):67-8 doi:10.58347/tml.2023.1675b | Show Introduction Hide Introduction
An EUA for Anakinra (Kineret) for COVID-19 (online only)
The Medical Letter on Drugs and Therapeutics • Dec 12, 2022 (Issue 1665)
An EUA for Anakinra (Kineret) for COVID-19
The recombinant interleukin-1 (IL-1) receptor ...
The recombinant interleukin-1 (IL-1) receptor
antagonist anakinra (Kineret – Sobi) has been
granted an FDA Emergency Use Authorization
(EUA) for treatment of hospitalized adults with
confirmed COVID-19 pneumonia who require low- or
high-flow supplemental oxygen, are at risk of
progressing to severe respiratory failure, and are
likely to have elevated plasma levels of soluble
urokinase plasminogen activator receptor (suPAR).
Anakinra has been available in the US for years; it
is FDA-approved for multiple indications, including
rheumatoid arthritis. Assays for suPAR are...
Fezolinetant (Veozah) for Menopausal Vasomotor Symptoms
The Medical Letter on Drugs and Therapeutics • Jun 26, 2023 (Issue 1679)
Fezolinetant (Veozah) for Menopausal Vasomotor Symptoms
Table 1. Pharmacology
Class Neurokinin 3 ...
Fezolinetant (Veozah – Astellas), a first-in-class
neurokinin 3 (NK3) receptor antagonist, has been
approved by the FDA for treatment of moderate to
severe vasomotor symptoms (VMS) due to menopause.
It is the second nonhormonal treatment to be approved
in the US for this indication; a low-dose formulation of
the selective serotonin reuptake inhibitor (SSRI)
paroxetine mesylate (Brisdelle) was approved in 2013.
Med Lett Drugs Ther. 2023 Jun 26;65(1679):97-9 doi:10.58347/tml.2023.1679a | Show Introduction Hide Introduction
Antibacterial Drugs for Community-Acquired Pneumonia
The Medical Letter on Drugs and Therapeutics • Jan 25, 2021 (Issue 1616)
Thoracic Society and the Infectious Diseases Society
of America (ATS/IDSA) were updated in 2019.1 ...
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 are
listed in Table 2; recommended antibiotic dosages for
treatment of CAP are listed in Tables 3 and 4. Joint
guidelines for treatment of CAP by the American
Thoracic Society and the Infectious Diseases Society of
America (ATS/IDSA) were updated in 2019.
COVID-19 Updates
The Medical Letter on Drugs and Therapeutics • Jan 24, 2022 (Issue 1642)
COVID-19 UPDATES
1. FDA News Release. Coronavirus (COVID-19) update: FDA takes
multiple actions ...
On January 3, the FDA amended its Emergency
Use Authorization (EUA) for the Pfizer-BioNTech
COVID-19 vaccine (Comirnaty) to incorporate the
following changes. The anti-SARS-CoV-2 antibody combinations
casirivimab plus imdevimab (REGEN-COV) and
bamlanivimab plus etesevimab are not active
against the Omicron variant of SARS-CoV-2.
COVID-19 Update: Novavax Vaccine Authorized for Adolescents 12-17 Years Old (online only)
The Medical Letter on Drugs and Therapeutics • Oct 03, 2022 (Issue 1660)
by Novavax to
include use of the vaccine as a two-dose primary
series in adolescents 12-17 years old.1 ...
The FDA has expanded its Emergency Use
Authorization for the adjuvanted protein subunit
COVID-19 vaccine manufactured by Novavax to
include use of the vaccine as a two-dose primary
series in adolescents 12-17 years old. The vaccine
was authorized for primary immunization of adults in
July 2022.
In Brief: Alternatives to Mifepristone for Medication Abortion
The Medical Letter on Drugs and Therapeutics • Jun 26, 2023 (Issue 1679)
’ gestation.1
MISOPROSTOL ALONE ― In a meta-analysis of 38
studies in 12,829 women with viable pregnancies ...
The possibility that use of mifepristone (Mifeprex,
and generics) may be restricted has led to questions
about alternatives for medication abortion.
Med Lett Drugs Ther. 2023 Jun 26;65(1679):102-3 doi:10.58347/tml.2023.1679d | Show Introduction Hide Introduction
Empagliflozin (Jardiance) for Type 2 Diabetes in Children (online only)
The Medical Letter on Drugs and Therapeutics • Aug 21, 2023 (Issue 1683)
has been available
since 2000 for this indication. The injectable
glucagon-like peptide-1 (GLP-1) receptor agonists ...
The sodium-glucose cotransporter 2 (SGLT2)
inhibitor empagliflozin has been available for years
alone (Jardiance – Boehringer Ingelheim) and in
combination with metformin (Synjardy) to improve
glycemic control in adults with type 2 diabetes. Both
products have now been approved for use in children
≥10 years old. Empagliflozin is the second oral drug
to become available in the US for treatment of type
2 diabetes in children; metformin has been available
since 2000 for this indication. The injectable
glucagon-like peptide-1 (GLP-1) receptor agonists
liraglutide (Victoza) and...
Med Lett Drugs Ther. 2023 Aug 21;65(1683):e137 doi:10.58347/tml.2023.1683e | Show Introduction Hide Introduction