The FDA has approved Vivlodex (Iroko), a low-dose formulation of the nonsteroidal anti-inflammatory drug meloxicam (Mobic, and generics), for management of osteoarthritis pain. According to the manufacturer, the new formulation aligns with stronger FDA warnings about the cardiovascular risks of NSAIDs and the recommendation to use the lowest possible doses of these drugs.

The FDA has approved a fixed-dose combination of lumacaftor and ivacaftor (Orkambi – Vertex) for oral treatment of cystic fibrosis (CF) in patients ≥12 years old who are homozygous for the F508del mutation. About 50% of patients in the US with CF are homozygous for the F508del (also called Phe508del) mutation. This is the first approved indication for lumacaftor; ivacaftor is available alone as Kalydeco for treatment of CF in patients ≥2 years old with other mutations. Orkambi is the first drug to be approved in the US for treatment of patients with the F508del...

The FDA has approved a rapidly disintegrating tablet formulation of the antiepileptic drug levetiracetam (Spritam – Aprecia) for adjunctive treatment of partialonset, myoclonic, and primary generalized tonicclonic seizures. Oral and intravenous formulations of levetiracetam (Keppra, and generics) have been available for years. Although approved by the FDA only as adjunctive therapy, levetiracetam is commonly used as monotherapy for partial-onset and generalized seizures and may also be effective in treating absence seizures and seizures of Lennox-Gastaut syndrome.

The FDA has approved subdermal implants of the partial opioid agonist buprenorphine (Probuphine – Titan) for maintenance treatment of opioid dependence in patients stabilized on low to moderate doses of transmucosal buprenorphine. Probuphine was designed to provide continuous low levels of buprenorphine for 6 months and to safeguard against illicit use of the drug.

The FDA has approved AspireAssist (Aspire Bariatrics), a weight-loss device that permits patients to drain a portion of their stomach contents through a gastrostomy tube into a toilet after each meal. It is approved for long-term use in combination with lifestyle modifications in adults ≥22 years old who have a body mass index (BMI) of 35 to 55 and have not been able to achieve and maintain weight loss with nonsurgical therapy.

The FDA has approved Vaxchora (PaxVax), a single-dose, oral, live-attenuated cholera vaccine, to protect against disease caused by Vibrio cholerae serogroup O1 in adults 18-64 years old traveling to cholera-affected areas. Vaxchora is the only cholera vaccine available in the US. A whole-cell killed injectable vaccine was previously approved, but is no longer available in the US.

The FDA has approved use of Exablate Neuro (Insightec) for unilateral thalamotomy to treat medication-refractory essential tremor in patients ≥22 years old. Exablate Neuro uses magnetic resonance-guided focused ultrasound (MRgFUS) to create lesions in the ventral intermediate nucleus of the thalamus. MRgFUS is also approved in the US for treatment of uterine fibroids and for pain palliation of bone metastases.

The FDA has approved abaloparatide (Tymlos – Radius Health), a synthetic analog of human parathyroid hormone related peptide, for treatment of postmenopausal women with osteoporosis who are at high risk for fracture. Abaloparatide is the second parathyroid hormone receptor agonist to be approved for this indication; teriparatide (Forteo – Lilly), a recombinant parathyroid hormone analog, was the first. They are the only drugs approved for treatment of osteoporosis that stimulate bone formation. Other drugs used for this indication inhibit bone resorption.

The FDA has approved edaravone (Radicava – Mitsubishi Tanabe Pharma) for treatment of amyotrophic lateral sclerosis (ALS). It is the second drug to be approved in the US for this indication; riluzole (Rilutek, and generics) was approved in 1995. Edaravone was approved for treatment of ALS as Radicut in Japan and South Korea in 2015. It has been used in Japan and other Asian countries since 2001 for treatment of acute ischemic stroke.

The FDA has approved obiltoxaximab (Anthim – Elusys Therapeutics), a toxin-targeting monoclonal antibody, for treatment of inhalational anthrax in combination with antibacterial drugs and prophylaxis of inhalational anthrax when other therapies are unavailable or inappropriate. Raxibacumab, another monoclonal antibody, was approved earlier for the same indication. Like raxibacumab, obiltoxaximab is being manufactured only for the CDC national stockpile and is not available for commercial sale.