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Review 9 new FDA-approved drugs that may soon find a place in your prescribing routine, including new treatments for migraine, CSU, RSV, and more.
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.)
For full prescribing information, please click here.
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)
For full prescribing information, please click here.
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.
Migraine and cluster headaches: Dihydroergotamine (Brekiya) injection, is the first and only dihydroergotamine autoinjector for the acute treatment of migraine and the acute treatment of cluster headaches in adults. (Approved 5/15/2025, Amneal Pharmaceuticals, Inc)
For full prescribing information, please click here.
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)
For full prescribing information, please click here.
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)
For full prescribing information, please click here.
Pain: Meloxicam (Xifyrm) injection, is a nonsteroidal anti-inflammatory drug (NSAID) indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Because of delayed onset of analgesia, Xifyrm alone is not recommended for use when rapid onset of analgesia is required. (Approved 6/05/2025, Azurity Pharmaceuticals, Inc.)
For full prescribing information, please click here.
Pre-exposure prophylaxis (PrEP) of HIV: Lenacapavir (Yeztugo) tablets and injection, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor indicated for PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents who weigh at least 35 kg who are at risk for HIV acquisition. Individuals must have a negative HIV-1 test prior to initiating treatment. (Approved 6/18/2025, Gilead Sciences, Inc)
For full prescribing information, please click here.
HTN: Chlorthalidone (HemiClor) tablets, is a thiazide-like diuretic indicated for the treatment of HTN in adults, to lower blood pressure. The recommended starting dose is 12.5 mg or 25 mg orally once daily; the dose may be doubled after 2-4 weeks as needed based on individual response. (Approved 4/16/2025, PRM Pharma, LLC)
For full prescribing information, please click here.
As another quarter rounds out, a new batch of drugs have been approved by the US FDA for conditions often seen in primary care. Above, find details on 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 more than a decade, and 7 more.
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