From acne to the menacing flu, we have picked the top 10 FDA-approved drugs every primary care physician should know about from the fourth quarter.
While a new year is already underway, let’s take a quick look back at fourth quarter 2018 and round out the year’s FDA approvals for drugs that treat conditions often seen in primary care. Scroll through the slideshow below to find details on the first new drug to treat influenza in 20 years; the first over-the-counter inhaler approved in the US; a digital inhaler with built-in sensors that connects to a mobile app; plus 7 more.
For a quick review of primary care drugs approved in the first quarter of 2018, please go to 9 New Drugs for Primary Care: Q1 2018
For a quick review of primary care drugs approved in the second quarter of 2018, please go to 10 New Drugs for Primary Care: Q2 2018
For a quick review of primary care drugs approved in the third quarter of 2018, please go to 9 New Drugs for Primary Care: Q3 2018
Bronchospasm Prophylaxis, Asthma, COPD: ProAir® Digihaler™ (albuterol sulfate) Inhalation Powder, is the first and only digital inhaler with built-in sensors that connects to a mobile application and provides inhaler use information for the treatment or prevention of bronchospasm in patients with chronic obstructive pulmonary disease (COPD) and asthma. ProAir® Digihaler™ is also approved for the prevention of exercise-induced bronchospasm in patients aged ≥4 years. (Approved 12/21/18, Teva Pharmaceutical Industries Ltd.) Full prescribing information, click here.
COPD: Yupelri (revefenacin) Inhalation Solution, is a long-acting muscarinic antagonist and the first and only once-daily, nebulized bronchodilator to be approved for the treatment of COPD in the US. (Approved 11/09/18, Theravance Biopharma, Inc.) Full prescribing information, click here.
Asthma: Primatene Mist (epinephrine) Inhalation Aerosol, is a metered dose inhaler with a non-chlorofluorocarbon propellant and is the first and only over-the-counter inhaler approved in the US for the temperorary relief of mild asthma in patients aged ≥12 years. (Approved 11/08/18, Amphastar Pharmaceuticals, Inc.) FDA approval history, click here.
Plaque Psoriasis: Bryhali (halobetasol propionate) Lotion 0.01% (formerly Jemdel), is a high-potency topical corticosteroid formulation for the treatment of plaque psoriasis in adult patients with safety established for dosing up to 8 weeks. (Approved 11/06/18, Ortho Dermatologics) Full prescribing information, click here.
Pain: Dsuvia (sufentanil) Sublingual Tablets, 30 mcg, a synthetic opioid analgesic formulation for the management of acute pain that is severe enough to require an opioid analgesic and for which alternative treatments have been inadequate. Dsuvia comes in a single-dose, pre-filled applicator that can only be administered by a healthcare professional. (Approved 11/02/18, AcelRx Pharmaceuticals, Inc.) Full prescribing information, click here.
Inflammatory Diseases: Hyrimoz (adalimumab-adaz) Injection, is an anti-TNF-Î± monoclonal antibody, biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. (Approved 10/30/18, Sandoz Inc.) Full prescribing information, click here.
Menopause: Bijuva (estradiol and progesterone) Capsules (formerly TX-001HR), a bio-identical hormone combination of 1 mg estradiol and 100 mg of progesterone for the treatment of moderate-to-severe vasomotor symptoms due to menopause in women. (Approved 10/28/18, TherapeuticsMD, Inc.) Full prescribing information, click here.
Influenza: Xofluza (baloxavir marboxil) Tablets, a polymerase acidic endonuclease inhibitor for the treatment of influenza in people aged ≥12 years who have experienced symptoms for no more than 2 days. (Approved 10/24/18, Genentech, Inc.) Full prescribing information, click here.
Acne: Seysara (sarecycline) Tablets, a once-daily, oral, narrow spectrum tetracycline-derived antibiotic for the treatment of inflammatory lesions of non-nodular, moderate-to-severe acne vulgaris in patients aged ≥9 years. (Approved 10/01/18, Almirall, S.A.) Full prescribing information, click here.
Diabetes Type 1, Type 2: Fiasp (insulin aspart) Injection, is a rapid-acting mealtime human insulin analog intended to improve glycemic control in adults with type 1 and type 2 diabetes mellitus. (Approved 9/29/18, Novo Nordisk) Full prescribing information, click here.