10 Drugs Approved for Primary Care From the First Half of 2025
Review FDA-approved drugs that may soon find a place in your prescribing routine, including new treatments for UTIs, acute pain, migraine, diabetes, and more.
Uncomplicated urinary tract infections (uUTIs): Gepotidacin (Blujepa) 750 mg, is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of female patients aged 12 years and older weighing at least 40 kg with uUTI caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis. (Approved 3/25/2025; GSK)
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Meningococcal disease prophylaxis: Penmenvy (meningococcal groups A, B, C, W, and Y vaccine), is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged 10 to 25 years. It is administered as an intramuscular injection and supplied as a lyophilized MenACWY component requiring reconstitution with a liquid MenB component before use. (Approved 2/14/2025; GSK plc)
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Diabetes: Insulin aspart-szjj (Merilog) injection, is a rapid acting human insulin analog biosimilar to NovoLog (insulin aspart) indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. It is the first rapid-acting insulin biosimilar product approved by the FDA. The approval is for both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial. (Approved 2/14/2025; Sanofi-Aventis US)
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Migraine: Meloxicam and rizatriptan (Symbravo), formerly AXS-07, is a combination of the rapidly absorbed COX-2 preferential NSAID meloxicam and the 5-HT1 receptor agonist rizatriptan, indicated for the acute treatment of migraine with or without aura in adults. It is not indicated for the preventive treatment of migraine or the treatment of cluster headache. (Approved 1/30/2025; Axsome Therapeutics)
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Pain management: Suzetrigine (Journavx) 50 mg, is a sodium channel blocker indicated for the treatment of moderate to severe acute pain in adults. Concomitant use with strong CYP3A inhibitors is contraindicated. (Approved 1/30/2025, Vertex Pharmaceuticals, Inc)
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Migraine: Dihydroergotamine (Atzumi) nasal powder (formerly STS101), is a novel ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults. It is not indicated for the preventive treatment of migraine or for managing hemiplegic migraine or migraine with brainstem aura. (Approved 4/30/2025, Satsuma Pharmaceuticals, Inc.)
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COVID-19 prevention: mRNA-1283 (mNEXSPIKE®), is a vaccine indicated for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is approved for use in adults aged 65 years and older, as well as people aged 12-64 years with at least one or more underlying risk factor as defined by the US CDC. (Approved 5/31/2025, Moderna)
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Respiratory syncytial virus (RSV) prevention: Clesrovimab-cfor (Enflonsia) injection, is an RSV F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. It is contraindicated in infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of clesrovimab. The approval marks the first non-weight-based RSV preventive monoclonal antibody available for this population. (Approved 6/09/2025, Merck)
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Hypertension (HTN): Amlodipine, indapamide and telmisartan (Widaplik™) tablets, formerly GMRx2, is a fixed-dose triple combination tablet indicated for the treatment of HTN in adults, including as initial treatment. (Approved 6/9/2025, George Medicines)
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Chronic spontaneous urticaria (CSU): Dupilumab (Dupixent) injection, received expanded approval as an add-on maintenance treatment for adults and adolescents aged ≥12 years with CSU who remain symptomatic despite treatment with H₁ antihistamines. Dupilumab is a monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling and is not classified as an immunosuppressant. (Approved 4/18/2025, Sanofi)
For full prescribing information, please click here.
The first half of 2025 brought a wave of new FDA drug approvals, several of which have direct relevance for primary care. In the slideshow above, we highlight 10 new therapies from the first and second quarter that may soon find a place in your prescribing routine. Click through the slides above for details on the first new oral antibiotic for uncomplicated urinary tract infections in 30 years, a vaccine that provides coverage against 5 major serogroups of Neisseria meningitidis that affect young people, the first dihydroergotamine nasal powder product to be approved for the acute treatment of migraine in adults, the first targeted therapy approved for chronic spontaneous urticaria (CSU) in over 10 years, and 6 more.
