7 New Approved Drugs for Primary Care: Q3 2023
First nonprescription daily oral contraceptive pill, OTC opioid antagonist nasal spray for opioid overdose, and 5 more FDA-approved drugs primary care clinicians should know about.
US Food and Drug Administration (FDA) new drug approvals in the third quarter of 2023 include numerous “firsts,” such as the first over-the-counter daily oral contraceptive pill, the first vaccine against respiratory syncytial virus (RSV) in neonates and children up to 24 months of age, the first oral medication for postpartum depression, and more. Find details on these and 4 more in the slides below.
Pregnancy prevention: Norgestrel (Opill®) tablets, a progestin-only pill that is the first nonprescription daily oral contraceptive to be approved by the FDA to prevent pregnancy. (Approved 7/13/23, HRA Pharma)
For full prescribing information, please click here.
Respiratory syncytial virus (RSV): Nirsevimab (Beyfortus®) injection, is the first RSV F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease (LRTD) in neonates and infants born during or entering their first RSV season and children up to 24 months of age who remain vulnerable to severe RSV through their second season. Nirsevimab was designed to protect a broad infant population including healthy neonates born at term, or preterm, or with specific health conditions that place them at high risk for RSV LRTD. (Approved 7/17/23, AstraZeneca)
For full prescribing information, please click here.
Opioid overdose: Naloxone hydrochloride (RiVive™) nasal spray, is an over-the-counter opioid antagonist nasal spray indicated for the emergency treatment of known or suspected opioid overdose. (Approved 7/28/23, Harm Reduction Therapeutics, Inc.)
For full prescribing information, please click here.
Postpartum depression (PPD): Zuranolone (Zurzuvae™) capsules, a neuroactive steroid gamma-aminobutyric acid A receptor positive modulator indicated for the treatment of PPD in adults. It is the first oral, once-daily treatment for PPD in adults. (Approved 8/4/23, Sage Therapeutics, Inc.)
For full prescribing information, please click here.
Multiple sclerosis, Crohn disease: Natalizumab-sztn (Tyruko®) injection, is the first FDA-approved biosimilar to the approved formulation of natalizumab (Tysabri®; Biogen) for the treatment of adults with relapsing forms of multiple sclerosis. It is also indicated for inducing and maintaining clinical response and remission in adults with moderately to severely active Crohn disease who also have evidence of inflammation and have had an inadequate response or inability to tolerate conventional therapies and inhibitors of tumor necrosis factor. (Approved 8/24/23, Sandoz Inc.)
For full prescribing information, please click here.
Major depressive disorder (MDD): Gepirone (Exxua®) extended-release tablets, a first-in-class medication indicated for the treatment of MDD in adults that selectively targets the serotonin 1A receptor in the brain. (Approved 9/22/23, Fabre-Kramer Pharmaceuticals Inc.)
For full prescribing information, please click here.
Chronic kidney disease: Empagliflozin (Jardiance®) tablets, a sodium-glucose co-transporter 2 inhibitor received a new indication to lower the risk of sustained decline in estimated glomerular filtration rate, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. (Approved 9/22/23, Eli Lilly and Company)
For full prescribing information, please click here.
