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In Brief: OTC Azelastine Nasal Spray 0.15% (Astepro Allergy) for Allergic Rhinitis
The Medical Letter on Drugs and Therapeutics • Oct 31, 2022 (Issue 1662)
intranasal antihistamine
Table 1. Intranasal H1-Antihistamines
Drug Usual Dosage Cost1
Azelastine 0.1%2 ...
The 0.15% nasal spray formulation of the H1-
antihistamine azelastine hydrochloride (Astepro
Allergy; Children's Astepro Allergy – Bayer) is now
available over the counter (OTC) for temporary relief
of nasal congestion, runny nose, sneezing, and itchy
nose due to allergic rhinitis in adults and children
≥6 years old. It is the first intranasal antihistamine
to be approved by the FDA for OTC use. Other drugs
that are available OTC for treatment of allergic rhinitis
symptoms include oral antihistamines, intranasal
corticosteroids, and mast cell stabilizers.
Ponesimod (Ponvory) for Multiple Sclerosis
The Medical Letter on Drugs and Therapeutics • Aug 09, 2021 (Issue 1630)
), a sphingosine 1-phosphate (S1P) receptor
modulator, for treatment of adults with relapsing
forms of multiple ...
The FDA has approved ponesimod (Ponvory –
Janssen), a sphingosine 1-phosphate (S1P) receptor
modulator, for treatment of adults with relapsing forms
of multiple sclerosis (MS), including clinically isolated
syndrome (initial neurological episode), relapsing-remitting
disease, and active secondary progressive
MS (SPMS). Ponesimod is the fourth oral S1P receptor
modulator to be approved in the US for once-daily
treatment of relapsing forms of MS; ozanimod
(Zeposia) and siponimod (Mayzent) are also approved
for use in adults, and fingolimod (Gilenya) is indicated
for use in patients...
Oliceridine (Olinvyk) - A New Opioid for Severe Pain
The Medical Letter on Drugs and Therapeutics • Mar 08, 2021 (Issue 1619)
treatment options are inadequate.1,2
MECHANISM OF ACTION — Binding of an opioid
agonist to μ-opioid ...
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 options are inadequate.
In Brief: Trijardy XR - A New 3-Drug Combination for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • Jun 01, 2020 (Issue 1599)
instructions for starting
treatment are complex.
1. Empagliflozin (Jardiance) for diabetes. Med Lett Drugs ...
The FDA has approved Trijardy XR (Boehringer Ingelheim/Lilly), a fixed-dose combination of the sodium-glucose
cotransporter 2 (SGLT2) inhibitor empagliflozin, the
dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, and
extended-release metformin, for oral treatment of type 2
diabetes in adults. Empagliflozin and linagliptin have been
available in a fixed-dose combination as Glyxambi since
2015, and both have been available in 2-drug combinations
with extended-release metformin for years (see Table 1).
Bexagliflozin (Brenzavvy) — A Fifth SGLT2 Inhibitor for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • Aug 21, 2023 (Issue 1683)
in the US for this indication
(see Table 4).1
SGLT2 INHIBITORS — SGLT2 inhibitors decrease renal
glucose reabsorption ...
Bexagliflozin (Brenzavvy – TheracosBio), a sodium-glucose
cotransporter 2 (SGLT2) inhibitor, has been
approved by the FDA to improve glycemic control
in adults with type 2 diabetes. It is the fifth SGLT2
inhibitor to be approved in the US for this indication
(see Table 4).
Med Lett Drugs Ther. 2023 Aug 21;65(1683):130-2 doi:10.58347/tml.2023.1683b | Show Introduction Hide Introduction
In Brief: Retifanlimab (Zynyz) for Merkel Cell Carcinoma (online only)
The Medical Letter on Drugs and Therapeutics • Apr 17, 2023 (Issue 1674)
), a programmed
death receptor-1 (PD-1) blocking antibody, has
received accelerated approval from the FDA ...
Retifanlimab-dlwr (Zynyz – Incyte), a programmed
death receptor-1 (PD-1) blocking antibody, has
received accelerated approval from the FDA for
treatment of metastatic or recurrent locally advanced
Merkel cell carcinoma (MCC) in adults. Accelerated
approval of the drug was based on the response rate
and duration of response. Retifanlimab is the third
drug to be approved in the US for treatment of MCC;
pembrolizumab (Keytruda), a PD-1 blocking antibody,
is approved for the same indication as retifanlimab
in patients ≥12 years old and avelumab (Bavencio),
a programmed death...
Med Lett Drugs Ther. 2023 Apr 17;65(1674):e73-4 doi:10.58347/tml.2023.1674h | Show Introduction Hide Introduction
Suflave — A Low-Volume Colonoscopy Preparation
The Medical Letter on Drugs and Therapeutics • Sep 18, 2023 (Issue 1685)
regimens are hyperosmotic and require consumption
of 2-3 liters of fluid.1
MECHANISM OF ACTION — Suflave ...
The FDA has approved Suflave (Sebela/Braintree), a
low-volume polyethylene glycol (PEG)- and sulfate-based
product for cleansing of the colon prior to
colonoscopy in adults. Other oral colonoscopy
preparations available in the US are listed in
Table 2. Suflave is marketed as tasting better than
other products.
Med Lett Drugs Ther. 2023 Sep 18;65(1685):148-51 doi:10.58347/tml.2023.1685b | Show Introduction Hide Introduction
Setmelanotide (Imcivree) for Rare Genetic Forms of Obesity (online only)
The Medical Letter on Drugs and Therapeutics • Jul 26, 2021 (Issue 1629)
subtilisin/kexin type 1 (PCSK1) deficiency, or leptin
receptor (LEPR) deficiency. for age (6 to ...
The FDA has approved setmelanotide (Imcivree –
Rhythm), a subcutaneously injected melanocortin 4
(MC4) receptor agonist, for chronic weight management
in patients ≥6 years old with obesity due to
pro-opiomelanocortin (POMC) deficiency, proprotein
subtilisin/kexin type 1 (PCSK1) deficiency, or leptin
receptor (LEPR) deficiency.
Bamlanivimab and Etesevimab for Post-Exposure Prophylaxis of COVID-19
The Medical Letter on Drugs and Therapeutics • Oct 18, 2021 (Issue 1635)
obstructive pulmonary disease
1. Adult and pediatric patients (≥12 years old and weighing ≥40 kg) with ≥1 ...
In February 2021, the FDA issued an Emergency Use
Authorization (EUA) for the investigational monoclonal
antibodies bamlanivimab and etesevimab (Lilly) for
use together to treat mild to moderate COVID-19
in persons ≥12 years old who weigh ≥40 kg and
are at high risk of progression to severe disease or
hospitalization. The FDA has now expanded this
EUA to allow use of the antibodies together for post-exposure
prophylaxis of COVID-19 in such persons
if they are not fully vaccinated against COVID-19 or
are unlikely to have an adequate immune response
to full vaccination and have...
Penbraya: A Pentavalent Meningococcal Vaccine
The Medical Letter on Drugs and Therapeutics • Mar 18, 2024 (Issue 1698)
, and Y (MenACWY; Menveo, MenQuadfi)1 and
two meningococcal serogroup B vaccines (MenB;
Bexsero ...
The FDA has licensed Penbraya (Pfizer), a pentavalent
polysaccharide conjugate meningococcal
vaccine, for prevention of invasive meningococcal
disease caused by Neisseria meningitidis
serogroups A, B, C, W, or Y (MenABCWY) in persons
10-25 years old. Penbraya is the only meningococcal
vaccine that contains all five of these serogroups.
Two quadrivalent polysaccharide conjugate
meningococcal vaccines containing serogroups A,
C, W, and Y (MenACWY; Menveo, MenQuadfi) and
two meningococcal serogroup B vaccines (MenB;
Bexsero, Trumenba) are available in the US (see
Table...
Med Lett Drugs Ther. 2024 Mar 18;66(1698):43-5 doi:10.58347/tml.2024.1698b | Show Introduction Hide Introduction