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Viltolarsen (Viltepso) for Duchenne Muscular Dystrophy

   
The Medical Letter on Drugs and Therapeutics • Oct 19, 2020  (Issue 1609)
oligonucleotide golodirsen (Vyondys 53) was approved in 2019.1 Pronunciation Key Viltolarsen: vil” toe lar’ sen ...
The antisense oligonucleotide viltolarsen (Viltepso – NS Pharma) has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have mutations of the dystrophin gene that are amenable to exon 53 skipping (DMD-53). It is the second drug to be approved for this indication; the antisense oligonucleotide golodirsen (Vyondys 53) was approved in 2019.
Med Lett Drugs Ther. 2020 Oct 19;62(1609):167 |  Show IntroductionHide Introduction

Two New Doses of Dulaglutide (Trulicity) for Diabetes

   
The Medical Letter on Drugs and Therapeutics • Oct 19, 2020  (Issue 1609)
Two New Doses of Dulaglutide (Trulicity) for Diabetes Table 1. Results of AWARD-111 A1C Change ...
The FDA has approved two additional doses (3 mg and 4.5 mg) of the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide (Trulicity – Lilly) for treatment of type 2 diabetes in adults. Dulaglutide has been available in 0.75- and 1.5-mg doses for years.
Med Lett Drugs Ther. 2020 Oct 19;62(1609):168 |  Show IntroductionHide Introduction

A New Indication for Esketamine Nasal Spray (Spravato)

   
The Medical Letter on Drugs and Therapeutics • Sep 21, 2020  (Issue 1607)
for treatment-resistant depression,1 has now been approved for treatment of depressive symptoms in adults ...
Esketamine (Spravato – Janssen), an intranasal N-methyl-D-aspartate (NMDA) receptor antagonist that was previously approved by the FDA for treatmentresistant depression,1 has now been approved for treatment of depressive symptoms in adults with major depressive disorder (MDD) and acute suicidal ideation or behavior. Esketamine is the S-enantiomer of the anesthetic ketamine (Ketalar, and generics). It is the first drug to be approved for this indication. Most clinical trials of antidepressants have excluded patients with acute suicidal ideation.
Med Lett Drugs Ther. 2020 Sep 21;62(1607):151 |  Show IntroductionHide Introduction

In Brief: Canagliflozin and Lower Limb Amputations

   
The Medical Letter on Drugs and Therapeutics • Sep 21, 2020  (Issue 1607)
of the drug.1 Package inserts for canagliflozin products still contain a standard warning about a risk ...
The FDA has removed a boxed warning from the labeling of products containing the sodium-glucose co-transporter 2 (SGLT2) inhibitor canagliflozin (Invokana, Invokamet, Invokamet XR) that described an increased risk of lower limb amputation associated with use of the drug. Package inserts for canagliflozin products still contain a standard warning about a risk of lower limb amputation.
Med Lett Drugs Ther. 2020 Sep 21;62(1607):152 |  Show IntroductionHide Introduction

Table: Correct Use of Inhalers for COPD (online only)

   
The Medical Letter on Drugs and Therapeutics • Sep 07, 2020  (Issue 1606)
a click is heard, the inhaler is ready to use The dose indicator should count down by 1 Exhale fully ...
View the Table: Correct Use of Inhalers for COPD
Med Lett Drugs Ther. 2020 Sep 7;62(1606):e150-4 |  Show IntroductionHide Introduction

Cenobamate (Xcopri) for Focal Seizures

   
The Medical Letter on Drugs and Therapeutics • Aug 24, 2020  (Issue 1605)
be tried as monotherapy before considering use of two drugs concurrently.1 Despite the availability ...
The FDA has approved cenobamate (Xcopri – SK Life Science) for oral treatment of partial-onset (focal) seizures in adults.
Med Lett Drugs Ther. 2020 Aug 24;62(1605):134-6 |  Show IntroductionHide Introduction

Phexxi - A Nonhormonal Contraceptive Gel

   
The Medical Letter on Drugs and Therapeutics • Aug 24, 2020  (Issue 1605)
), but was never marketed.1 Phexxi — A Nonhormonal Contraceptive Gel CHOICE OF CONTRACEPTIVES — Intrauterine ...
The FDA has approved Phexxi (Evofem), a nonhormonal prescription-only vaginal gel containing lactic acid, citric acid, and potassium bitartrate, for prevention of pregnancy. The gel is intended for on-demand contraception; it is not effective when used after intercourse. It was previously approved for use as a vaginal lubricant (Amphora), but was never marketed.
Med Lett Drugs Ther. 2020 Aug 24;62(1605):129-32 |  Show IntroductionHide Introduction

Ozanimod (Zeposia) for Multiple Sclerosis

   
The Medical Letter on Drugs and Therapeutics • Aug 24, 2020  (Issue 1605)
), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple ...
The FDA has approved ozanimod (Zeposia – Celgene), 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). It is the third oral S1P receptor modulator to be approved in the US for treatment of relapsing forms of MS; siponimod (Mayzent) is also indicated for use in adults, and fingolimod (Gilenya) is approved for use in patients ≥10 years old.
Med Lett Drugs Ther. 2020 Aug 24;62(1605):132-4 |  Show IntroductionHide Introduction

IV Artesunate for Severe Malaria

   
The Medical Letter on Drugs and Therapeutics • Aug 10, 2020  (Issue 1604)
in children and adults. It has been available from the CDC on a compassionate use basis since 2007.1 ...
Artesunate for injection (Amivas LLC), a semi-synthetic artemisinin derivative, is now approved by the FDA for initial (induction) treatment of severe malaria in children and adults. It has been available from the CDC on a compassionate use basis since 2007. Artemether/lumefantrine (Coartem), another artemisinin-based drug, was approved earlier for oral treatment of uncomplicated Plasmodium falciparum malaria. IV artesunate is now the only FDA-approved injectable antimalarial drug available in the US; IV quinidine has been discontinued.
Med Lett Drugs Ther. 2020 Aug 10;62(1604):121-4 |  Show IntroductionHide Introduction

Drugs Past Their Expiration Date

   
The Medical Letter on Drugs and Therapeutics • Jul 27, 2020  (Issue 1603)
on the label. Since our last article on this subject,1 more data have become available. SAFETY ...
Healthcare providers are often asked if drugs can be used past their expiration date. Because of legal restrictions and liability concerns, manufacturers do not sanction such use and usually do not comment on the safety or effectiveness of their products beyond the date on the label. Since our last article on this subject, more data have become available.
Med Lett Drugs Ther. 2020 Jul 27;62(1603):117-9 |  Show IntroductionHide Introduction