10 Drugs Approved for Primary Care: Q1 2025

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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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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Pregnancy prevention: Miudella, is a copper-containing intrauterine system indicated for prevention of pregnancy in women of reproductive potential for up to 3 years. It is the first hormone-free, low-dose copper intrauterine device to be approved by the FDA in the US in over 40 years. (Approved 2/24/2025; Sebela Women’s Health Inc.)

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Asthma maintenance, chronic rhinosinusitis with nasal polyps (CRSwNP), food allergies, urticaria: Omalizumab-igec (Omlyclo), is the first FDA-approved anti-IgE biosimilar to omalizumab designated as interchangeable with omalizumab (Xolair). It is indicated for the treatment of moderate to severe persistent asthma, CRSwNP, IgE-mediated food allergy, and chronic spontaneous urticaria in patients who remain symptomatic despite antihistamine therapy. (Approved 3/7/2025; Celltrion Inc)

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Crohn disease: Guselkumab (Tremfya) injection, a selective interleukin-23 inhibitor, was awarded a label expansionto include the treatment of adults with moderately to severely active Crohn disease. Guselkumab was previously approved to treat plaque psoriasis, psoriatic arthritis, and ulcerative colitis. Before initiating treatment, liver enzymes and bilirubin levels should be obtained. (Approved 3/20/2025; Johnson & Johnson)

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Osteoporosis: Denosumab-dssb (Ospomyv) injection, is a RANK ligand inhibitor biosimilar to Prolia (denosumab) indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in men with osteoporosis at high risk for fracture, treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and for the treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. (Approved 2/13/2025; Samsung Bioepis Co., Ltd.)

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Hypertension (HTN): Losartan potassium (Arbli) oral suspension, 10 mg/mL, is an oral liquid formulation of the approved angiotensin II receptor blocker losartan for use in the treatment of HTN in patients aged 6 years and older, for the reduction of risk of stroke in patients with HTN and left ventricular hypertrophy, and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes. It is the first and only FDA-approved ready-to-use oral liquid losartan available in the US. (Approved 3/13/2025; Scienture Holdings, Inc.)

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