Slide Show: FDA drug approvals in the second quarter 2017 included these 10 for conditions seen in the primary care setting.
"I have always stuck up for Western medicine. You can chew all the celery you want, but without antibiotics, three- quarters of us would not be here." - Hugh Laurie
1. Allergic Reactions and Anaphylaxis: Symjepi (epinephrine) injection,
a non-selective alpha- and beta-adrenergic receptor agonist, is available in a single-dose, prefilled syringe for emergency treatment of allergic reactions (Type I). Symjepi provides two single-dose syringes of epinephrine for immediate administration in acute anaphylactic reactions to insect stings or bites, allergic reaction to foods, drugs, other allergens, and idiopathic or exercise-induced anaphylaxis.
(Approved 6/15/17, Adamis Pharmaceuticals Corporation)
2. HIV/AIDS: Isentress (raltegravir),
is now available as a 1200 mg once-daily dose, administered orally as two 600 mg film-coated tablets with or without food, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg, who are treatment-naÃ¯ve or whose virus has been suppressed on an initial regimen of Isentress 400 mg given twice daily.
(Approved 5/30/17, Merck)
3. Allergic Conjunctivitis: Zerviate (cetirizine hydrochloride) Ophthalmic Solution (formerly AC-170)
is the first topical histamine-1 receptor antagonist ophthalmic formulation for the treatment of ocular itching associated with allergic conjunctivitis.
(Approved 5/30/17, Nicox Ophthalmics, Inc.)
4. Rheumatoid Arthritis: Kevzara (sarilumab) injection,
is an IL-6 receptor antagonist indicated for adults with moderately to severely active RA who have had an inadequate response or intolerance to one or more DMARDs.
(Approved 5/22/17, Sanofi and Regeneron Pharmaceuticals, Inc.)
5. Pain: RoxyBond (oxycodone hydrochloride) Tablets,
an immediate-release, abuse-deterrent, narcotic analgesic formulation for management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate..
(Approved 5/20/17, Inspirion Delivery Sciences, LLC)
6. Osteoporosis: Tymlos (abaloparatide) injection,
a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein) for the treatment of postmenopausal women with osteoporosis.
(Approved 4/28/17, Radius Health, Inc.)
7. Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis: Renflexis (infliximab-abda) injection,
a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for reducing signs and symptoms of Crohn disease, UC, RA, PSA, ankylosing spondylitis, and plaque psoriasis.
(Approved 4/21/17, Samsung Bioepis Co., Ltd.)
8. Migraine Prophylaxis: Qudexy XR (topiramate) extended-release capsules.
FDA has approved an expanded indication for topiramate extended release capsules to include prophylaxis of migraines in adults and adolescents.
(Approved 3/29/17, Upsher-Smith)
9. Atopic Dermatitis: Dupixent (dupilumab) injection,
an interleukin-4 receptor alpha antagonist indicated for treatment of inadequately controlled moderate-to-severe atopic dermatitis in adults. Intended for eczema that is not controlled adequately by topical therapies, and when topical therapies are not advisable. Can be used with or without topical corticosteroids.
(Approved 3/28/17, Sanofi and Regeneron Pharmaceuticals, Inc.)
2017 has been a busy year for the FDA. In March we reviewed 10 of the many drugs approved in the first quarter (see link below) that are appropriate for primary care. Click through the slides above for 10 more, either newly approved or granted a new indication during the April-June timeframe.For a quick review of 10 primary care drugs approved in the first three months of the year, please go to Top 10 Primary Care Drugs Approved in Early 2017. Top 10 Primary Care Drugs Approved in Early 2017Â