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The Medical Letter on Drugs and Therapeutics • January 24, 2022 (Issue 1642)
On December 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug nirmatrelvir copackaged with the HIV-1 protease inhibitor ritonavir (Paxlovid – Pfizer) for oral treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh at least 40 kg and are at high risk of progressing to severe disease, including hospitalization or...
The Medical Letter on Drugs and Therapeutics • January 24, 2022 (Issue 1642)
The FDA has removed the requirement that mifepristone (Mifeprex, and generics), a progestin receptor antagonist approved for use in a regimen with the prostaglandin E1 analog misoprostol (Cytotec, and generics) for medical termination of pregnancy, must be dispensed in person to the patient.
The Medical Letter on Drugs and Therapeutics • January 24, 2022 (Issue 1642)
On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody combinations casirivimab plus imdevimab (REGEN-COV) and bamlanivimab plus etesevimab are not active against the Omicron variant of SARS-CoV-2.
The Medical Letter on Drugs and Therapeutics • January 24, 2022 (Issue 1642)
The investigational oral antiviral drug molnupiravir (Merck/Ridgeback Biotherapeutics) was granted an FDA Emergency Use Authorization (EUA) on December 23, 2021 for treatment of mild to moderate COVID-19 in outpatients ≥18 years old who are at high risk of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative treatment options are not...
The Medical Letter on Drugs and Therapeutics • January 10, 2022 (Issue 1641)
The FDA has issued an Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to be administered concomitantly by IM injection for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of severe allergy that prevents their vaccination against COVID-19...
The Medical Letter on Drugs and Therapeutics • January 10, 2022 (Issue 1641)
Invega Hafyera (Janssen), a long-acting, extended-release (ER) formulation of the second-generation antipsychotic paliperidone palmitate, has been approved by the FDA for twice-yearly IM treatment of schizophrenia in adults who have been adequately treated with another injectable ER formulation of the drug (Invega Sustenna or Invega Trinza). It is the first drug to become...
The Medical Letter on Drugs and Therapeutics • January 10, 2022 (Issue 1641)
View the Comparison Chart: Antiviral Drugs for Influenza for 2021-2022
The Medical Letter on Drugs and Therapeutics • December 27, 2021 (Issue 1640)
On November 19, the FDA expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to include administration of a booster dose for all adults ≥18 years old after primary immunization with either the same COVID-19 vaccine or a different one. Booster doses of these vaccines were previously...
The Medical Letter on Drugs and Therapeutics • December 13, 2021 (Issue 1639)
The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly), which was approved by the FDA in 2017 for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant...
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 vaccine manufactured by Johnson...
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 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...
The Medical Letter on Drugs and Therapeutics • October 29, 2021 (Issue 1636)
View the COVID-19 Vaccine Dosing Recommendations
The Medical Letter on Drugs and Therapeutics • October 20, 2021 (Issue )
View the Table: Over the Counter At-Home Tests for COVID-19
The Medical Letter on Drugs and Therapeutics • October 18, 2021 (Issue 1635)
On September 22, on the advice of its Vaccines and Related Biologic Products Advisory Committee, the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine (Comirnaty) to include administration of a booster dose ≥6 months after a 2-dose primary series in adults who are ≥65 years old or at high risk for severe COVID-19 because of an underlying...
The Medical Letter on Drugs and Therapeutics • October 4, 2021 (Issue 1634)
Annual vaccination against influenza A and B viruses is recommended for everyone ≥6 months old without a contraindication.1 Available influenza vaccines for the 2021-2022 season are listed in Table 2.
The Medical Letter on Drugs and Therapeutics • October 4, 2021 (Issue 1634)
Insulin glargine-yfgn (Semglee – Viatris), a follow-on insulin glargine product, has now received interchangeability status with the reference product Lantus from the FDA. It is the first biosimilar insulin product to receive this designation in the US. Now a pharmacist can substitute Semglee for Lantus as a lower-cost alternative without permission from the prescriber...
The Medical Letter on Drugs and Therapeutics • October 4, 2021 (Issue 1634)
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...
The Medical Letter on Drugs and Therapeutics • September 20, 2021 (Issue 1633)
The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to include administration of a third dose in persons ≥12 years old (Pfizer/BioNTech) or ≥18 years old (Moderna) who have undergone solid organ transplantation or have a condition that compromises the immune system to a...
The Medical Letter on Drugs and Therapeutics • September 20, 2021 (Issue 1633)
The FDA has approved a higher-dose intranasal naloxone formulation (Kloxxado – Hikma) for emergency treatment of opioid overdose. A single spray of the new formulation delivers 8 mg of naloxone; a formulation that delivers 4 mg per spray (Narcan) was approved in 2015.
The Medical Letter on Drugs and Therapeutics • August 23, 2021 (Issue 1631)
In a clinical trial conducted by the CDC's Tuberculosis Trials Consortium in collaboration with the NIH-funded AIDS Clinical Trials Group, a new 4-month regimen for treatment of drug-susceptible pulmonary tuberculosis was found to be noninferior to 6 months of standard treatment.