As another quarter rounds out, a new batch of drugs have been approved by the US Food and Drug Administration for conditions often seen in primary care. Scroll through the slides below to find details on a first-in-class topical androgen receptor inhibitor for the treatment of acne; a novel attachment inhibitor for adults with multidrug-resistant HIV-1 infection; and 5 more.
HIV: Rukobia (fostemsavir) Extended-Release Tablets, 600 mg, is a novel attachment inhibitor indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations; one tablet to be taken twice daily with or without food. (Approved 7/2/20, ViiV Healthcare)
For full prescribing information, please click here.
Inflammatory Diseases: Hulio (adalimumab-fkjp) Injection, is a tumor necrosis factor blocker, biosimilar to Humira® (adalimumab), approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (patients aged ≥4 years), psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis. (Approved 7/6/20, Mylan Pharmaceuticals Inc.)
For full prescribing information, please click here.
Plaque Psoriasis: Wynzora (calcipotriene and betamethasone dipropionate) Cream, 0.005%/0.064%, is a topical treatment for plaque psoriasis in adults aged ≥18 years to be applied to affected areas once-daily for up to 8 weeks and can be discontinued when control is achieved. (Approved 7/20/20, MC2 Therapeutics)
For full prescribing information, please click here.
Chronic Obstructive Pulmonary Disease (COPD): Breztri Aerosphere (budesonide 160 mcg/glycopyrrolate 9 mcg/formoterol fumarate 4.8 mcg) Metered Dose Inhalation, is a fixed dose triple-combination of budesonide, an inhaled corticosteroid; glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist, indicated for the maintenance treatment of patients with COPD. (Approved 7/23/20, AstraZeneca)
For full prescribing information, please click here.
Head Lice: Xeglyze (abametapir) Topical Lotion, 0.74%, is a pediculicide indicated for the topical treatment of head lice infestation in patients aged ≥6 months and should be used in the context of an overall lice management program. (Approved 7/24/20, Dr. Reddy’s Laboratories, Inc.)
For full prescribing information, please click here.
Acne: Winlevi (clascoterone) Cream, 1%, is a first-in-class topical androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients aged ≥12 years. (Approved 8/26/20, Cassiopea SpA)
For full prescribing information, please click here.
Pain: Qdolo (tramadol hydrochloride) Oral Solution, 5mg/mL, is an opioid agonist that received a New Drug Application approval for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. (Approved 9/01/20, Athena Bioscience, LLC)
For a quick review of primary care drugs approved in the second quarter of 2020, check out 8 New Drugs for Primary Care: Q2 2020.
For a quick review of primary care drugs approved in the first quarter of 2020, check out 9 New Drugs for Primary Care: Q1 2020.
