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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.
Med Lett Drugs Ther. 2021 Jan 11;63(1615):5-7 |  Show IntroductionHide Introduction

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.
Med Lett Drugs Ther. 2021 Feb 8;63(1617):e24-5 |  Show IntroductionHide Introduction

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...
Med Lett Drugs Ther. 2021 Apr 5;63(1621):53-4 |  Show IntroductionHide Introduction

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.
Med Lett Drugs Ther. 2022 Feb 21;64(1644):26-8 |  Show IntroductionHide Introduction

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 IntroductionHide 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 IntroductionHide 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).
Med Lett Drugs Ther. 2022 Jun 27;64(1653):97-104 |  Show IntroductionHide Introduction

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.
Med Lett Drugs Ther. 2021 Mar 8;63(1619):37-9 |  Show IntroductionHide Introduction

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
Med Lett Drugs Ther. 2022 May 30;64(1651):e89-91 |  Show IntroductionHide Introduction

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 IntroductionHide Introduction