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COVID-19 Update: FDA Authorizes Novavax COVID-19 Vaccine

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The FDA has issued an Emergency Use Authorization (EUA) for an adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax. The vaccine is indicated for use as a two-dose primary series to prevent...
The FDA has issued an Emergency Use Authorization (EUA) for an adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax. The vaccine is indicated for use as a two-dose primary series to prevent COVID-19 in adults; it is not authorized for use in children or as a booster dose. Three other COVID-19 vaccines are available in the US for primary immunization of adults; the mRNA vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) are FDA-licensed for this indication, and the adenovirus-based vaccine manufactured by Johnson & Johnson (Janssen) is available under an EUA for use in adults who are unable or unwilling to receive another COVID-19 vaccine.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):121-2 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Dosing Interval for Tixagevimab/Cilgavimab (Evusheld) (online only)

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The FDA has amended its Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to recommend repeat dosing every 6...
The FDA has amended its Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to recommend repeat dosing every 6 months in patients who require ongoing protection against COVID-19. Evusheld is authorized for IM pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of a severe adverse reaction that prevents their vaccination against COVID-19 or moderate or severe immune compromise
Med Lett Drugs Ther. 2022 Aug 8;64(1656):e122-3 | Show Full IntroductionHide Full Introduction

Tapinarof Cream (Vtama) for Psoriasis

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The FDA has approved Vtama (Dermavant), a 1% cream formulation of the aryl hydrocarbon receptor (AhR) agonist tapinarof, for treatment of adults with plaque psoriasis. It is the first AhR agonist to...
The FDA has approved Vtama (Dermavant), a 1% cream formulation of the aryl hydrocarbon receptor (AhR) agonist tapinarof, for treatment of adults with plaque psoriasis. It is the first AhR agonist to be approved by the FDA.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):122-4 | Show Full IntroductionHide Full Introduction

Oteseconazole (Vivjoa) for Recurrent Vulvovaginal Candidiasis

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The FDA has approved oteseconazole (Vivjoa – Mycovia), a new oral azole antifungal, to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC. Oteseconazole...
The FDA has approved oteseconazole (Vivjoa – Mycovia), a new oral azole antifungal, to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC. Oteseconazole is the first drug to be approved in the US specifically for treatment of RVVC.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):124-6 | Show Full IntroductionHide Full Introduction

Lumateperone (Caplyta) for Bipolar Depression

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The oral second-generation antipsychotic drug lumateperone (Caplyta – Intra-Cellular Therapies), which was approved by the FDA in 2020 for treatment of schizophrenia, is now approved for use...
The oral second-generation antipsychotic drug lumateperone (Caplyta – Intra-Cellular Therapies), which was approved by the FDA in 2020 for treatment of schizophrenia, is now approved for use as monotherapy or as an adjunct to lithium or valproate for treatment of depressive episodes associated with bipolar I or II disorder in adults.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):126-8 | Show Full IntroductionHide Full Introduction

A Donepezil Patch (Adlarity) for Alzheimer's Disease (online only)

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
A once-weekly transdermal formulation of the acetylcholinesterase inhibitor donepezil (Adlarity – Corium) has been approved by the FDA for treatment of mild, moderate, and severe Alzheimer's disease (AD)...
A once-weekly transdermal formulation of the acetylcholinesterase inhibitor donepezil (Adlarity – Corium) has been approved by the FDA for treatment of mild, moderate, and severe Alzheimer's disease (AD) dementia. Donepezil is the second acetylcholinesterase inhibitor to become available in a transdermal formulation; transdermal rivastigmine (Exelon Patch), which is applied once daily, has been available for years for the same indication. Donepezil is also available in oral formulations (Aricept, and generics) for treatment of AD dementia.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):e128-9 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Prescription of Paxlovid by Pharmacists (online only)

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed...
The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed pharmacists in certain situations. Paxlovid is authorized for oral treatment of mild to moderate COVID-19 in high-risk outpatients ≥12 years old who weigh at least 40 kg. NIH guidelines list it as the treatment of choice for COVID-19 in high-risk adult outpatients.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):e124 | Show Full IntroductionHide Full Introduction

Tezepelumab (Tezspire) for Severe Asthma

   
The Medical Letter on Drugs and Therapeutics • February 21, 2022;  (Issue 1644)
Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen), a subcutaneously administered thymic stromal lymphopoietin (TSLP) blocker, has been approved by the FDA for add-on maintenance treatment of severe asthma...
Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen), a subcutaneously administered thymic stromal lymphopoietin (TSLP) blocker, has been approved by the FDA for add-on maintenance treatment of severe asthma in patients ≥12 years old. It is the first TSLP blocker to become available in the US and the first biologic drug to be approved for treatment of severe asthma without phenotypic or biomarker limitations.
Med Lett Drugs Ther. 2022 Feb 21;64(1644):25-6 | Show Full IntroductionHide Full Introduction

Remimazolam (Byfavo) for Short-Term Procedural Sedation

   
The Medical Letter on Drugs and Therapeutics • February 21, 2022;  (Issue 1644)
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'...
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 Full IntroductionHide Full Introduction

Odevixibat (Bylvay) for Progressive Familial Intrahepatic Cholestasis-Associated Pruritus

   
The Medical Letter on Drugs and Therapeutics • February 21, 2022;  (Issue 1644)
Odevixibat (Bylvay – Albireo), an oral ileal bile acid transporter (IBAT) inhibitor, has been approved by the FDA for treatment of pruritus in patients ≥3 months old with progressive familial...
Odevixibat (Bylvay – Albireo), an oral ileal bile acid transporter (IBAT) inhibitor, has been approved by the FDA for treatment of pruritus in patients ≥3 months old with progressive familial intrahepatic cholestasis (PFIC). It is the first drug to be approved in the US for this indication.
Med Lett Drugs Ther. 2022 Feb 21;64(1644):28 | Show Full IntroductionHide Full Introduction

Cabotegravir (Apretude) for HIV-1 Pre-Exposure Prophylaxis

   
The Medical Letter on Drugs and Therapeutics • February 21, 2022;  (Issue 1644)
The FDA has approved Apretude (ViiV Healthcare), an IM extended-release (ER) formulation of the integrase strand transfer inhibitor (INSTI) cabotegravir, for use every 2 months to prevent sexually...
The FDA has approved Apretude (ViiV Healthcare), an IM extended-release (ER) formulation of the integrase strand transfer inhibitor (INSTI) cabotegravir, for use every 2 months to prevent sexually acquired HIV-1 infection in at-risk adolescents and adults. Apretude is the first ER formulation to be FDA-approved for pre-exposure prophylaxis (PrEP) of HIV-1 infection.
Med Lett Drugs Ther. 2022 Feb 21;64(1644):29-31 | Show Full IntroductionHide Full Introduction

COVID-19 Updates

   
The Medical Letter on Drugs and Therapeutics • February 21, 2022;  (Issue 1644)
The IV antiviral drug remdesivir (Veklury – Gilead) has been available for treatment of COVID-19 in hospitalized patients since 2020. Now, the FDA has approved remdesivir for treatment of mild to...
The IV antiviral drug remdesivir (Veklury – Gilead) has been available for treatment of COVID-19 in hospitalized patients since 2020. Now, the FDA has approved remdesivir for treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh ≥40 kg and are at high risk for progression to severe disease, including hospitalization or death; they also issued an Emergency Use Authorization (EUA) allowing its use in any other high-risk outpatient who weighs ≥3.5 kg.
Med Lett Drugs Ther. 2022 Feb 21;64(1644):31-2 | Show Full IntroductionHide Full Introduction

Booster Doses of COVID-19 Vaccines

   
The Medical Letter on Drugs and Therapeutics • November 29, 2021;  (Issue 1638)
The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) and the adenovirus-based...
The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) and the adenovirus-based vaccine manufactured by Johnson & Johnson/Janssen to include administration of a booster dose in select populations after primary immunization with either the same COVID-19 vaccine or a different one.
Med Lett Drugs Ther. 2021 Nov 29;63(1638):186-8 | Show Full IntroductionHide Full Introduction

Two New Pneumococcal Vaccines - Prevnar 20 and Vaxneuvance

   
The Medical Letter on Drugs and Therapeutics • November 29, 2021;  (Issue 1638)
The FDA has licensed two new pneumococcal conjugate vaccines (PCVs) for prevention of invasive pneumococcal disease in adults: Prevnar 20 (PCV20; Pfizer), which contains antigens from 20 serotypes...
The FDA has licensed two new pneumococcal conjugate vaccines (PCVs) for prevention of invasive pneumococcal disease in adults: Prevnar 20 (PCV20; Pfizer), which contains antigens from 20 serotypes of pneumococcus, and Vaxneuvance (PCV15; Merck), which contains antigens from 15 serotypes. Two other pneumococcal vaccines are available in the US: Prevnar 13 (PCV13; Pfizer), a 13-valent conjugate vaccine licensed for use in persons ≥6 weeks old, and Pneumovax 23 (PPSV23; Merck), a 23-valent pneumococcal polysaccharide vaccine licensed for use in persons ≥2 years old.
Med Lett Drugs Ther. 2021 Nov 29;63(1638):188-90 | Show Full IntroductionHide Full Introduction

Olanzapine/Samidorphan (Lybalvi) for Schizophrenia and Bipolar Disorder

   
The Medical Letter on Drugs and Therapeutics • November 29, 2021;  (Issue 1638)
The FDA has approved Lybalvi (Alkermes), a fixed-dose combination of the second-generation antipsychotic olanzapine (Zyprexa, and generics) and samidorphan, a new opioid antagonist, for treatment of adults...
The FDA has approved Lybalvi (Alkermes), a fixed-dose combination of the second-generation antipsychotic olanzapine (Zyprexa, and generics) and samidorphan, a new opioid antagonist, for treatment of adults with schizophrenia or with manic or mixed episodes of bipolar I disorder. The addition of samidorphan is intended to mitigate the weight gain that occurs with olanzapine. This is the first FDA approval for samidorphan.
Med Lett Drugs Ther. 2021 Nov 29;63(1638):191-2 | Show Full IntroductionHide Full Introduction

In Brief: Pfizer/BioNTech COVID-19 Vaccine Authorized for Children 5-11 Years Old

   
The Medical Letter on Drugs and Therapeutics • November 29, 2021;  (Issue 1638)
The FDA has issued an Emergency Use Authorization (EUA) for a lower-strength (10 mcg/0.2 mL) formulation of the mRNA-based COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) for use in children...
The FDA has issued an Emergency Use Authorization (EUA) for a lower-strength (10 mcg/0.2 mL) formulation of the mRNA-based COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) for use in children 5-11 years old. The original formulation of (Comirnaty) (30 mcg/0.3 mL) is FDA-licensed for use in persons ≥16 years old and available under an EUA for use in adolescents 12-15 years old.
Med Lett Drugs Ther. 2021 Nov 29;63(1638):185 | Show Full IntroductionHide Full Introduction

In Brief: Dapagliflozin (Farxiga) for Chronic Kidney Disease

   
The Medical Letter on Drugs and Therapeutics • July 26, 2021;  (Issue 1629)
The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) has been approved by the FDA for treatment of adults with chronic kidney disease (CKD) at risk of...
The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) has been approved by the FDA for treatment of adults with chronic kidney disease (CKD) at risk of progression (not defined in the label). Dapagliflozin is the first SGLT2 inhibitor to be approved in the US for treatment of CKD.
Med Lett Drugs Ther. 2021 Jul 26;63(1629):115 | Show Full IntroductionHide Full Introduction

Sunscreens

   
The Medical Letter on Drugs and Therapeutics • July 26, 2021;  (Issue 1629)
Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and...
Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and safety. The FDA has issued a proposed rule that would require manufacturers to perform additional safety studies for some sunscreen active ingredients and would mandate better UVA protection in sunscreen products. Some sunscreen products containing FDA-approved active ingredients are listed in Table 2.
Med Lett Drugs Ther. 2021 Jul 26;63(1629):115-20 | Show Full IntroductionHide Full Introduction

Addendum: Aducanumab (Aduhelm) for Alzheimer's Disease

   
The Medical Letter on Drugs and Therapeutics • July 26, 2021;  (Issue 1629)
In June 2021, the FDA approved the IV amyloid beta-directed monoclonal antibody aducanumab (Aduhelm) for treatment of Alzheimer’s disease. The approval did not restrict use of the drug to patients with...
In June 2021, the FDA approved the IV amyloid beta-directed monoclonal antibody aducanumab (Aduhelm) for treatment of Alzheimer’s disease. The approval did not restrict use of the drug to patients with mild cognitive impairment or mild dementia, which was the population enrolled in the clinical trials. Now, Biogen, with the permission of the FDA, has made an addition to the labeling of the drug that says: Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
Med Lett Drugs Ther. 2021 Jul 26;63(1629):120 | Show Full IntroductionHide Full Introduction

In Brief: Johnson & Johnson COVID-19 Vaccine Suspended (online only)

   
The Medical Letter on Drugs and Therapeutics • May 3, 2021;  (Issue 1623)
On April 13, 2021, the FDA and CDC advised suspending use of the Johnson & Johnson adenovirus-based COVID-19 vaccine while the agencies investigate 6 cases of cerebral venous sinus thrombosis (CVST)...
On April 13, 2021, the FDA and CDC advised suspending use of the Johnson & Johnson adenovirus-based COVID-19 vaccine while the agencies investigate 6 cases of cerebral venous sinus thrombosis (CVST) and thrombocytopenia that occurred following administration of the vaccine. In an April 14 emergency meeting, the Advisory Committee on Immunization Practices (ACIP) recommended continuing the suspension until more data become available. About 7 million people in the US have received the Johnson & Johnson vaccine.
Med Lett Drugs Ther. 2021 May 3;63(1623):e1 | Show Full IntroductionHide Full Introduction