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Searched for establish. Results 91 to 100 of 144 total matches.
Metoclopramide Nasal Spray (Gimoti) for Diabetic Gastroparesis
The Medical Letter on Drugs and Therapeutics • Jan 11, 2021 (Issue 1615)
levels, has an effect on milk
production has not been established.
DOSAGE AND ADMINISTRATION ...
The FDA has approved Gimoti (Evoke), a nasal
spray formulation of the dopamine-2 (D2) receptor
antagonist metoclopramide, for relief of symptoms in
adults with acute and recurrent diabetic gastroparesis.
Metoclopramide (Reglan, and generics) has been
available for years in conventional and orally-disintegrating
tablets and in an injectable formulation.
It is the only drug that is FDA-approved for treatment
of diabetic gastroparesis.
Sacituzumab Govitecan (Trodelvy) for Metastatic Triple-Negative Breast Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Feb 08, 2021 (Issue 1617)
months), and an optimal sequence of treatment has
not been established.1,2
Some patients with advanced ...
The FDA has approved sacituzumab govitecan-hziy
(Trodelvy – Immunomedics), a trophoblast cell-surface
antigen-2 (Trop-2)-directed antibody and topoisomerase
inhibitor conjugate, for treatment of adults with metastatic
triple-negative breast cancer who have received ≥2 prior
therapies for metastatic disease. It is the first Trop-2-directed antibody-drug conjugate to become available in the US.
Semaglutide (Ozempic) for Weight Loss
The Medical Letter on Drugs and Therapeutics • Apr 05, 2021 (Issue 1621)
cardiovascular events in adults with type 2 diabetes
and established cardiovascular disease, has reduced
body ...
In recently published clinical trials, once-weekly
subcutaneous injection of the glucagon-like peptide 1
(GLP-1) receptor agonist semaglutide (Ozempic – Novo Nordisk), which is FDA-approved for treatment of
type 2 diabetes and to reduce the risk of major adverse
cardiovascular events in adults with type 2 diabetes
and established cardiovascular disease, has reduced
body weight significantly in patients with and without
type 2 diabetes when given in addition to lifestyle
intervention. Liraglutide (Saxenda), another GLP-1
receptor agonist, has been FDA-approved for chronic
weight...
Remimazolam (Byfavo) for Short-Term Procedural Sedation
The Medical Letter on Drugs and Therapeutics • Feb 21, 2022 (Issue 1644)
to
be established, but its ultra-short duration of action
requires more frequent intraprocedural administration ...
The FDA has approved remimazolam (Byfavo – Acacia
Pharma), an ultra-short-acting IV benzodiazepine,
for induction and maintenance of sedation in adults
undergoing procedures of up to 30 minutes' duration.
Elacestrant (Orserdu) for Advanced or Metastatic Breast Cancer
The Medical Letter on Drugs and Therapeutics • Mar 06, 2023 (Issue 1671)
in earlier lines
of treatment remains to be established.
Table 2. Endocrine Therapy for Breast Cancer ...
The FDA has approved elacestrant (Orserdu –
Stemline), an oral estrogen receptor antagonist, for
treatment of estrogen receptor (ER)-positive, human
epidermal growth factor receptor 2 (HER2)-negative,
estrogen receptor 1 (ESR1)-mutated advanced or
metastatic breast cancer in postmenopausal women
or men who had disease progression following
endocrine therapy. Elacestrant is the first oral selective
estrogen receptor degrader (SERD) to be approved
for treatment of breast cancer; the injectable SERD
fulvestrant (Faslodex, and generics) was approved
more than 20 years...
Med Lett Drugs Ther. 2023 Mar 6;65(1671):38-40 doi:10.58347/tml.2023.1671d | Show Introduction Hide Introduction
Gepirone (Exxua) for Depression
The Medical Letter on Drugs and Therapeutics • Jun 24, 2024 (Issue 1705)
the QT interval. Other antidepressants
with better established records of efficacy and safety ...
The FDA has approved an oral extended-release
formulation of gepirone (Exxua – Fabre-Kramer), a
selective 5-HT1A receptor agonist, for treatment of
major depressive disorder (MDD) in adults. Gepirone
was originally developed decades ago for treatment
of anxiety and depression, but it was not approved by
the FDA for such use. Gepirone is structurally related
to buspirone, which is FDA-approved for treatment
of anxiety.
Med Lett Drugs Ther. 2024 Jun 24;66(1705):97-9 doi:10.58347/tml.2024.1705a | Show Introduction Hide Introduction
Drugs for Sexually Transmitted Infections
The Medical Letter on Drugs and Therapeutics • Jun 27, 2022 (Issue 1653)
not established; for use only when patient is allergic to penicillin. Adherence must be ensured.
29. Limited data ...
This article includes recommendations for management
of most sexually transmitted infections (STIs)
other than HIV and viral hepatitis. Some of the
indications and dosages recommended here have
not been approved by the FDA (see Table 1).
Oliceridine (Olinvyk) - A New Opioid for Severe Pain
The Medical Letter on Drugs and Therapeutics • Mar 08, 2021 (Issue 1619)
has not been
established.
TOLERANCE — Tolerance to the analgesic effect of
opioids develops at least as rapidly ...
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.
Comparison Table: Some FDA-Approved Drugs for Weight Management (online only)
The Medical Letter on Drugs and Therapeutics • May 30, 2022 (Issue 1651)
has not been established
▶ Increases oxalate absorption and may increase the
risk of developing calcium oxalate kidney ...
View the Comparison Table: Some FDA-Approved Drugs for Weight Management
Vibrant – An Oral Vibrating Capsule for Chronic Idiopathic Constipation
The Medical Letter on Drugs and Therapeutics • May 01, 2023 (Issue 1675)
and its long-term efficacy
and safety remain to be established.
The Vibrant capsule consists of a motor ...
The Vibrant orally administered vibrating capsule
(Vibrant Gastro), an FDA-cleared medical device, is
now available by prescription for treatment of adults
with chronic idiopathic constipation (CIC) who have
not experienced relief of their bowel symptoms
by using laxative therapies at the recommended
dosage for at least one month. It is the first drug-free
treatment to be authorized by the FDA for this
indication.
Med Lett Drugs Ther. 2023 May 1;65(1675):65-7 doi:10.58347/tml.2023.1675a | Show Introduction Hide Introduction