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Searched for vol. Results 91 to 100 of 365 total matches.
In Brief: New Warnings for Janus Kinase Inhibitors
The Medical Letter on Drugs and Therapeutics • Oct 04, 2021 (Issue 1634)
September 15, 2021.
161
The Medical Letter ® Vol. 63 (1634) October 4, 2021 Xeljanz upadacitinib ...
The FDA has required updates to the boxed warnings
in the labeling of the Janus kinase (JAK) inhibitors
tofacitinib (Xeljanz, Xeljanz XR), baricitinib (Olumiant),
and upadacitinib (Rinvoq) describing increased risks
of major adverse cardiovascular events, malignancy,
thrombosis, and death with their use. The new warnings
were prompted by the results of a postmarketing safety
trial with tofacitinib and were added to the labels of
baricitinib and upadacitinib based on the presumption
of a class effect. The tofacitinib package insert had
contained a boxed warning about an increased...
In Brief: Furoscix - A Subcutaneous Furosemide Infusor for Heart Failure
The Medical Letter on Drugs and Therapeutics • Jan 23, 2023 (Issue 1668)
/policies/drug-pricing-policy.
The Medical Letter ® Vol. 65 (1668) January 23, 2023 heart failure diuretics ...
The FDA has approved Furoscix (scPharmaceuticals),
a subcutaneous formulation of the loop diuretic
furosemide administered via a single-use, on-body
infusor, for treatment of congestion due to fluid
overload in adults with New York Heart Association
(NYHA) Class II-III chronic heart failure (HF).
Furosemide (Lasix, and generics) has been available
for years in oral and IV formulations.
Med Lett Drugs Ther. 2023 Jan 23;65(1668):14-5 doi:10.58347/tml.2023.1668d | Show Introduction Hide Introduction
In Brief: Rezvoglar - Another Insulin Glargine Product Interchangeable with Lantus
The Medical Letter on Drugs and Therapeutics • Apr 03, 2023 (Issue 1673)
(AL, IN, SC, and WA)
restrict interchangeability entirely.4
The Medical Letter ® Vol. 65 (1673 ...
Insulin glargine-aglr (Rezvoglar – Lilly), which was
approved by the FDA as a biosimilar to the reference
product Lantus in 2021 and received interchangeability
status with Lantus in 2022, will become available in
the US on April 1, 2023. It is the second biosimilar
insulin product to be designated as interchangeable
with Lantus; Semglee was the first. Rezvoglar did not
receive interchangeability status with Lantus at the
time of its initial approval because the manufacturer
of Semglee had exclusivity for 12 months.
Med Lett Drugs Ther. 2023 Apr 3;65(1673):56 doi:10.58347/tml.2023.1673c | Show Introduction Hide Introduction
In Brief: Alternatives to Mifepristone for Medication Abortion
The Medical Letter on Drugs and Therapeutics • Jun 26, 2023 (Issue 1679)
duration of ≤63 days’ gestation,
a regimen consisting of a single intramuscular
The Medical Letter ® Vol ...
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)
® Vol. 65 Published online August 21, 2023 Synjardy type 2 diabetes Victoza liraglutide Jardiance ...
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
Bremelanotide (Vyleesi) for Hypoactive Sexual Desire Disorder
The Medical Letter on Drugs and Therapeutics • Jul 29, 2019 (Issue 1577)
of satisfying
115
The Medical Letter ® Vol. 61 (1577) July 29, 2019
Table 2. Results of RECONNECT Trials ...
The FDA has approved bremelanotide (Vyleesi – Amag),
a melanocortin receptor agonist, for subcutaneous
treatment of premenopausal women with acquired,
generalized hypoactive sexual desire disorder (HSDD).
Bremelanotide is not approved for use in men or
postmenopausal women. It is the second drug to
be approved in the US for this indication; flibanserin
(Addyi), which was approved in 2015, was the first.
Solriamfetol (Sunosi) for Excessive Daytime Sleepiness
The Medical Letter on Drugs and Therapeutics • Aug 26, 2019 (Issue 1579)
® Vol. 61 (1579) August 26, 2019
Table 2. Solriamfetol 12-Week Efficacy Trial Results
MWT ESS
Regimen ...
The FDA has approved solriamfetol (Sunosi – Jazz),
a dopamine and norepinephrine reuptake inhibitor
(DNRI), to improve wakefulness in adults with excessive
daytime sleepiness (EDS) associated with narcolepsy
or obstructive sleep apnea (OSA). Pitolisant (Wakix),
an H3-receptor antagonist/inverse agonist recently
approved by the FDA for treatment of excessive
daytime sleepiness in patients with narcolepsy, will be
reviewed in a future issue.
Dolutegravir/Lamivudine (Dovato) - A Two-Drug Complete Regimen for HIV-1 Infection
The Medical Letter on Drugs and Therapeutics • Aug 26, 2019 (Issue 1579)
)
▶ Not recommended in patients with CrCl ...
The FDA has approved Dovato (ViiV), a fixed-dose
combination of the integrase strand transfer inhibitor
(INSTI) dolutegravir (Tivicay) and the nucleoside
reverse transcriptase inhibitor (NRTI) lamivudine
(Epivir, and generics), as a once-daily complete
regimen for treatment of adults with HIV-1 infection
who are antiretroviral-treatment naive and have no
known substitutions associated with resistance
to either drug. Dolutegravir/lamivudine is the first
complete regimen to be approved by the FDA for
initial treatment of HIV-1 infection that contains 2
rather than 3 antiretroviral...
Trifarotene (Aklief) - A New Topical Retinoid for Acne
The Medical Letter on Drugs and Therapeutics • Dec 16, 2019 (Issue 1587)
significance is not known.5
196
The Medical Letter ® Vol. 61 (1587) December 16, 2019
site pruritus (2.4% vs ...
The FDA has approved trifarotene 0.005% cream
(Aklief – Galderma) for topical treatment of acne
vulgaris in patients ≥9 years old. Trifarotene is the
fourth topical retinoid to be approved in the US for
treatment of acne; tretinoin (Retin-A, and others),
adapalene (Differin, and generics), and tazarotene
(Tazorac, and others) have been available by
prescription for decades. Adapalene 0.1% gel has been
available over the counter since 2016 for treatment of
acne in patients ≥12 years old.
Letermovir (Prevymis) for CMV Prophylaxis
The Medical Letter on Drugs and Therapeutics • Dec 16, 2019 (Issue 1587)
to have
had a primary endpoint event. Compared to placebo,
200
The Medical Letter ® Vol. 61 (1587) December ...
The FDA has approved letermovir (Prevymis – Merck),
a cytomegalovirus (CMV) DNA terminase complex
inhibitor, for prophylaxis of CMV infection and disease
in CMV-seropositive adult recipients of an allogeneic
hematopoietic cell transplant (HCT). Letermovir is
the first CMV DNA terminase complex inhibitor to
be approved in the US and the only drug specifically
indicated for CMV prophylaxis in HCT patients. It is not
approved for treatment of CMV infection.