The Medical Letter - 2026
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January 19, 2026 (Issue 1746)
- Sublingual Cyclobenzaprine (Tonmya) for Fibromyalgia The FDA has approved Tonmya (Tonix), a sublingual tablet formulation of the skeletal muscle relaxant cyclobenzaprine, for treatment of fibromyalgia in adults. Cyclobenzaprine is available in...
- Nalmefene Autoinjector (Zurnai) for Reversal of Opioid Overdose Zurnai (Purdue), an autoinjector formulation of the opioid antagonist nalmefene, has been approved by the FDA for intramuscular (IM) or subcutaneous (SC) emergency treatment of known or suspected opioid...
- Donidalorsen (Dawnzera) for Prevention of Hereditary Angioedema Attacks Donidalorsen (Dawnzera – Ionis), a subcutaneously injected prekallikrein-directed antisense oligonucleotide, has been approved by the FDA for prevention of hereditary angioedema (HAE) attacks in...
- Imlunestrant (Inluriyo) for Advanced Breast Cancer The FDA has approved imlunestrant (Inluriyo – Lilly), an oral estrogen receptor antagonist, for treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative,...
- In Brief: A New Indication for Uzedy Uzedy, an extended-release, subcutaneous (SC) formulation of the second-generation antipsychotic drug risperidone, was approved by the FDA in 2023 for treatment of schizophrenia in adults. It has now...
- In Brief: Andexanet alfa (Andexxa) Withdrawn Andexanet alfa (Andexxa – AstraZeneca), which received accelerated approval from the FDA in 2018 for urgent reversal of the anticoagulant effect of the direct factor Xa inhibitors apixaban (Eliquis) and...
January 5, 2026 (Issue 1745)
- Gepotidacin (Blujepa) — A New Antibiotic for Uncomplicated UTI The FDA has approved gepotidacin (Blujepa – GSK), a triazaacenaphthylene bacterial type II topoisomerase inhibitor, for oral treatment of uncomplicated urinary tract infections (uUTI) in female patients...
- Remibrutinib (Rhapsido) for Chronic Spontaneous Urticaria The FDA has approved remibrutinib (Rhapsido – Novartis), an oral Bruton's tyrosine kinase (BTK) inhibitor, for treatment of chronic spontaneous urticaria in adults who remain symptomatic...
- Drugs Past Their Expiration Date 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...
- In Brief: Alternatives to Bicillin L-A On July 10, 2025 Pfizer issued a voluntary recall of certain lots of long-acting intramuscular (IM) benzathine penicillin G (Bicillin L-A) due to particulates identified during visual inspection. The CDC...
- Correction In our recent article titled Expanded Indication for PCSK9 Inhibitors (Med Lett Drugs Ther 2025; 67:201), the number needed to treat (NNT) to prevent one composite endpoint of myocardial infarction,...