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At the close of the first quarter of a new year, Patient Care Online has compiled a list of 7 new FDA-approved drugs for conditions that are often seen in primary care. Scroll through the slides below to find details on a new oral solution of amlodipine; the first and only FDA-approved, once-daily amphetamine transdermal patch for the treatment of attention deficit hyperactivity disorder; and 5 more.
Insomnia: Daridorexant tablets (Quviviq®), an orexin receptor antagonist indicated for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. The recommended dosage is 25 mg to 50 mg once per night, taken orally within 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening. It is anticipated to be available to patients in May 2022, pending controlled substance scheduling by the FDA. (Approved 1/7/2022, Idorsia Ltd.)
For full prescribing information, please click here.
Atopic dermatitis: Abrocitinib tablets (Cibinqo®), a Janus kinase (JAK) inhibitor indicated for the treatment of adults with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. It is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or immunosuppressants. (Approved 1/14/2022; Pfizer Inc)
For full prescribing information, please click here.
Allergic rhinitis: Olopatadine hydrochloride and mometasone furoate nasal spray (Ryaltris®), a combination of olopatadine, a histamine-1 receptor inhibitor, and mometasone furoate, a corticosteroid, indicated for the treatment of symptoms of seasonal allergic rhinitis in patients aged ≥12 years. The recommended dosage is 2 sprays per nostril twice daily. (Approved 1/13/2022, Glenmark Pharmaceuticals, Inc.)
For full prescribing information, please click here.
COVID-19 prevention: Spikevax (formerly mRNA-1273), a vaccine indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adults aged ≥18 years. Spikevax is administered intramuscularly as a series of 2 doses (0.5 mL each) 1 month apart. (Approved 1/31/2022, Moderna, Inc.)
For the full prescribing information, please click here.
Cardiovascular diseases: Amlodipine oral solution (Norliqva®), 1 mg/mL, a calcium channel blocker indicated for the treatment of hypertension in patients aged ≥6 years, and coronary artery disease (chronic stable angina, vasospastic angina, and angiographically documented coronary artery disease) in patients without heart failure or an ejection fraction <40%. Norliqva is supplied as a peppermint flavored oral solution and is administered once daily. (Approved 1/24/2022, CMP Pharma Inc.)
For full prescribing information, please click here.
Allergic rhinitis: Mometasone furoate monohydrate 50 mcg (Nasonex® 24HR Allergy), a corticosteroid nasal spray, was FDA-approved for over-the-counter use for the temporary relief of the symptoms of hay fever or other upper respiratory allergies. (Approved 3/17/2022; Perrigo Company plc)
For the product label, please click here.
Attention deficit hyperactivity disorder (ADHD): Dextroamphetamine transdermal system CII (Xelstrym®), the first and only FDA-approved, once-daily amphetamine transdermal patch for the treatment of ADHD in adults and children aged ≥6 years, applied 2 hours before an effect is needed and removed within 9 hours after application. (Approved 3/22/2022, Noven Pharmaceuticals, Inc.)
For full prescribing information, please click here.
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