The FDA has approved Odactra (ALK), a sublingual allergen extract, for immunotherapy in adults 18-65 years old with house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis. Odactra is the first sublingual allergen extract to be approved in the US for this indication. Three other sublingual allergen extracts were approved earlier (see Table 1).

The FDA has approved a sublingual tablet (Nocdurna – Ferring) and a nasal spray (Noctiva – Avadel) formulation of desmopressin acetate for treatment of nocturia due to nocturnal polyuria in adults who wake up ≥2 times per night to void. Nocdurna and Noctiva are the first two products to be approved in the US for this indication. Higher-strength nasal spray and oral tablet formulations of desmopressin (DDAVP, and others) have been available for years for treatment of diabetes insipidus and primary nocturnal enuresis (bedwetting in children). In 2007, the indication for primary...

Oliceridine (Olinvyk - Trevena), an IV opioid agonist, has been approved by the FDA for management of acute pain severe enough to require an opioid and for which alternative treatment options are inadequate.

The FDA has approved a long-acting fixed-dose combination of the stimulant dexmethylphenidate and the prodrug serdexmethylphenidate (Azstarys – Corium) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Azstarys is the first product containing serdexmethylphenidate to become available in the US.

View the Comparison Table: Some FDA-Approved Drugs for Weight Management

Gabapentin (Neurontin - Pfizer), which has been available in the US since 1994, is approved by the FDA only for treatment of partial epilepsy and postherpetic neuralgia, but is widely used off-label for a number of other indications, especially neuropathic pain syndromes. According to one report, among Medicaid recipients in Florida receiving gabapentin, 71% of prescriptions were for chronic pain and 8% for seizures and neuralgia ("The Pink Sheet" February 2, 2004; 66:30).

Olodaterol (Striverdi Respimat – Boehringer Ingelheim), a new inhaled long-acting beta2-agonist, has been approved by the FDA for once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). It is not approved for treatment of acute exacerbations of COPD or for treatment of asthma. Olodaterol is the third long-acting beta2-agonist to be approved by the FDA for once-daily use; indacaterol (Arcapta Neohaler), which is available as a single agent, and vilanterol, which is available only in fixed-dose combinations with the...

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide, previously approved by the FDA for treatment of type 2 diabetes as Victoza, has now also been approved at a higher dose as Saxenda (Novo Nordisk) for chronic weight management in adults with a BMI ≥30, or a BMI ≥27 with a weight-related comorbidity such as hypertension, dyslipidemia, or diabetes.

The FDA has approved Namzaric (Forest), a fixed-dose combination of extended-release (ER) memantine (Namenda XR), an NMDA-receptor antagonist, and donepezil (Aricept, and generics), an acetylcholinesterase inhibitor, for treatment of moderate to severe Alzheimer's type dementia in patients previously stabilized on both drugs. The patent for Namenda has recently expired and generic formulations of memantine 5- and 10-mg tablets have been approved.

The FDA has approved a fixed-dose, orally inhaled combination of the long-acting anticholinergic tiotropium and the long-acting beta2-adrenergic agonist olodaterol (Stiolto Respimat — Boehringer Ingelheim) for long-term, once-daily, maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). It is not approved for treatment of acute exacerbations of COPD or for treatment of asthma. Tiotropium (Spiriva Handihaler, Spiriva Respimat) and olodaterol (Striverdi Respimat) are also available separately for once-daily treatment of...