12 Drugs Approved for Primary Care in 2019
ICYMI: Get a quick look at 12 of the many drugs FDA-approved in 2019 for conditions commonly seen in primary care.
"It is much more important to know what sort of a patient has a disease than what sort of a disease a patient has." - Author unknown
Migraine: Tosymra (sumatriptan) Nasal Spray, is a single-dose, serotonin receptor agonist approved for the acute treatment of migraine with or without aura in adults. Tosymra is formulated with a novel excipient to achieve blood levels similar to injection of 4-mg sumatriptan, accelerating onset of action. (Approved 1/25/19, Promius Pharma, LLC)
For full prescribing information, please click here.
Gout: Gloperba (colchicine) Oral Solution, is the first liquid solution of colchicine approved for the prophylaxis of gout flares in adults and can be used either once or twice per day. (Approved 1/30/19, Romeg Therapeutics, LLC)
For full prescribing information, please click here.
Asthma, COPD: Wixela Inhub (fluticasone propionate and salmeterol) Inhalation Powder (Advair Diskus® generic), is the first generic version of Advair Diskus® to receive approval for the twice-daily treatment of asthma in patients aged ≥4 years (100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg )and for maintenance treatment and reduction of exacerbations in patients with COPD (250 mcg/50 mcg). (Approved 1/30/19, Mylan N.V.)
For full prescribing information, please click here.
Obesity: Plenity (cellulose and citric acid) Capsusles, is a non-systemic, superabsorbent hydrogel in capsules that increase the volume and elasticity of the stomach and small intestine to mimic the feeling the fullness. Plenity is used in conjunction with diet and exercise in adults with a body mass index of 25-40 kg/m2 to aid in weight management and is the only prescription weight management product to be cleared for use by overweight adults with a BMI as low as 25 kg/m.2 Plenity will be available by prescription in the US in 2020. (Approved 4/12/19, Gelesis)
For FDA approval history, please click here.
Opioid Overdose: Naloxone Hydrochloride Nasal Spray, 4mg, (Narcan® Nasal Spray generic), is the first FDA-approved generic naloxone hydrochloride nasal spray that is designed for use by people without medical training to stop or reverse the effects of an opioid overdose. (Approved 4/19/19, Teva Pharmaceuticals, Inc.)
For full prescribing information, please click here.
Type 2 Diabetes Mellitus (T2DM): Qternmet XR (dapagliflozin, metformin hydrochloride, and saxagliptin) Extended-Release Tablets, a SGLT-2 inhibitor (dapagliflozin), DPP-4 inhibitor (saxagliptin), and biguanide (metformin hydrochloride) combination indicated for once-daily use along with diet and exercise to improve glycemic control in patients with T2DM. (Approved 5/2/19, AstraZeneca)
For full prescribing information, please click here,
Asthma: AirDuo® Digihaler™ (fluticasone propionate 113 µcg and salmeterol 14 µcg) Inhalation Powder, the first digital maintenance inhaler that has built-in sensors that connect to a mobile app via Bluetooth® to record and store information on inhaler use. It combines a breath-actuated, multi-dose dry powder inhaler with an inhaled corticosteroid (fluticasone propionate) and a long-acting beta2-adrenergic-agonist (salmeterol) to treat asthma in patients aged ≥12 years. (Approved 7/15/19, Teva Pharmaceuticals Inc.)
For full prescribing information, please click here.
Hypoglycemia: Baqsimi (glucagon) Nasal Powder, 3mg, the first noninjectable glucagon therapy approved for the emergency treatment of severe hypoglycemia that is administered with a single-use dry powder dispenser. Baqsimi is indicated for patients with diabetes aged ≥4 years. (Approved 7/24/19, Eli Lilly and Company)
For full prescribing information, please click here.
Hypoglycemia: Gvoke (glucagon) Ready-to-Use Injection, the first FDA-approved premade stable liquid glucagon to quickly treat severe hypoglycemia in patients with diabetes aged ≥2 years; available in 0.5mg/0.1mL for pediatric patients and 1mg/0.2mL for adolescent and adult patients. (Approved 9/10/19, Xeris Pharmaceuticals, Inc.)
For full prescribing information, please click here.
Type 2 Diabetes Mellitus (T2DM): Rybelsus (semaglutide) Tablets, the first and only glucagon-like peptide-1 analog in pill form indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM who are not responding to current treatment; available in 7mg or 14mg tablets. (Approved 9/20/19, Novo Nordisk)
For full prescribing information, please click here.
Migraine: Reyvow (lasmitidan) Tablets is a first-in-class serotonin (5-HT)1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults. Reyvow is not indicated for preventive treatment of migraine and has not been studied in pediatric patients. Reyvow is available in 50 mg and 100 mg tablets and can be prescribed to patients in oral doses of 50 mg, 100 mg, and 200 mg as needed. (Approved 10/11/19, Eli Lilly and Company)
For full prescribing information, please click here.
Helicobacter pylori infection: Talicia (omeprazole magnesium 10 mg, amoxicillin 250 mg, and rifabutin 12.5 mg) Capsules is a delayed-release, fixed-drug combination for the treatment of H. pylori infection in adults. TALICIA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Talicia is administered in 4-capsule doses every 8 hours with food for 14 days. (Approved 11/4/19, RedHill Biopharma Ltd.)
For full prescribing information please click here.
For a quick review of more primary care drugs approved in 2019, please go to:
10 New Drugs for Primary Care: Q1 2019
7 New Drugs for Primary Care: Q2 2019
10 New Drugs for Primary Care: Q3 2019
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New drugs were approved for many conditions commonly treated in primary care in all 4 quarters in 2019 - quite a few of them first-in-class or novel in another way: The first liquid solution of colchicine for gout The first generic Advair Diskus inhaler for asthma and COPD A novel weight-loss drug that is the first approved for BMI as low as 25 25 kg/m2 The first generic naloxone spray The first oral GLP-1 receptor agonist and a glucagon nasal spray for hypoglycemiaIn the spirit of the holiday, we highlight 12 of the 2019 FDA approvals to prep primary care clinicians for 2020.
