10 New Drugs for Primary Care: Q4 2019

Urticaria: Quzyttir (cetirizine hydrochloride) Injection, 10 mg/mL, is a histamine-1 receptor antagonist indicated for the treatment of acute urticaria in adults and children aged ≥6 months. (Approved 10/4/19, TerSera Therapeutics LLC)

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Migraine: Reyvow (lasmiditan) Tablets, a first-in-class serotonin (5-HT)_1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults; available in 50 mg and 100 mg tablets and can be prescribed in oral doses of 50 mg, 100 mg, and 200 mg as needed. (Approved 10/11/19, Eli Lilly and Company)

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Pregnancy Prevention: EluRyng (ethinyl estradiol, 2.7 mg and etonogestrel, 11.7 mg) Vaginal Ring, the first generic version of NuvaRing^® to receive FDA approval, is an estrogen/progestin combination hormonal contraceptive to prevent pregnancy. (Approved 10/11/19, Amneal Pharmaceuticals, Inc.)

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Cystic Fibrosis (CF): Trikafta (elexacaftor 100 mg, tezacaftor 50 mg, ivacaftor 75 mg and ivacaftor, 75 mg) Tablets, the first triple combination therapy approved to treat patients aged ≥12 years who have at least 1 F508del mutation in the CF transmembrane conductance regulator gene, the most common CF mutation. (Approved 10/21/19, Vertex Pharmaceuticals)

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Helicobacter pylori Infection: Talicia (omeprazole magnesium 10 mg, amoxicillin 250 mg, and rifabutin 12.5 mg) Capsules, a delayed-release, fixed-drug combination for the treatment of H. pylori infection in adults that is administered in 4-capsule doses every 8 hours with food for 14 days. (Approved 11/4/19, RedHill Biopharma Ltd.)

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Acne: Amzeeq (minocycline) Topical Foam (formerly FMX101), 4%, a novel tetracycline-class drug indicated for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged ≥9 years. It is the first topical minocycline to be approved for any condition. (Approved 11/18/19, Foamix Pharmaceuticals)

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Acne: Arazlo (tazarotene) Lotion, 0.045%, the first tazarotene topical treatment available in a lotion form to treat acne vulgaris in patients aged ≥9 years. (Approved 12/18/19, Bausch Health Companies Inc.)

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Hypertension: Conjupri (levamlodipine maleate) Tablets, 1.25 mg, 2.5 mg, 5 mg, a calcium channel blocker that may be used alone or combined with other antihypertensive medication for the treatment of hypertension; adult recommended starting dose is 2.5 mg once daily with maximum dose 5 mg once daily and pediatric starting dose is 1.25 mg-2.5 mg once daily. (Approved 12/19/19, CSPC Pharmaceutical Group Limited)

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Insomnia: Dayvigo (lemborexant) Tablets, 5 mg, 10 mg, a dual orexin receptor antagonist to treat adults with insomnia (characterized by difficulties with sleep onset and/or sleep maintenance) to be taken no more than once/night immediately before bedtime. (Approved 12/20/19, Eisai Co., Ltd.)

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Migraine: Ubrelvy (ubrogepant) Tablets, 50 mg, 100 mg, the first and only FDA-approved oral calcitonin gene-related peptide receptor antagonist for the acute treatment of migraine with or without aura in adults. (Approved 12/23/19, Allergan plc)

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For a quick review of primary care drugs approved in the first quarter of 2019, check out 10 New Drugs for Primary Care: Q1 2019

For a quick review of primary care drugs approved in the second quarter of 2019, check out 7 New Drugs for Primary Care: Q2 2019

For a quick review of primary care drugs approved in the third quarter of 2019, check out 10 New Drugs for Primary Care: Q3 2019