Dronedarone (Multaq - Sanofi-Aventis) has been approved by the FDA for oral treatment of atrial fibrillation and flutter. Amiodarone (Cordarone, and others) is the most effective drug for this indication, but has considerable toxicity.

The FDA has approved tramadol hydrochloride extended-release (Ryzolt – Purdue) for treatment of moderate to moderately severe chronic pain in adults. Tramadol is already available in another extended-release formulation (Ultram ER) and in immediate-release tablets alone (Ultram, and others) and combined with acetaminophen (Ultracet, and others).

The FDA has approved Anjeso (Baudax Bio), an IV formulation of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam, for once-daily treatment of moderate to severe pain in adults. Oral meloxicam (Mobic, and others), which is only indicated for treatment of chronic pain associated with osteoarthritis or rheumatoid arthritis, has been available for 20 years. IV formulations of ketorolac, ibuprofen (Caldolor), and acetaminophen (Ofirmev) are also available for treatment of pain.

The FDA has approved stiripentol (Diacomit – Biocodex) for treatment of seizures in patients ≥2 years old with Dravet syndrome who are also taking clobazam (Onfi). Stiripentol, which has been available in Europe, Canada, and Japan for many years, is the second drug to be approved in the US for this indication; cannabidiol oral solution (Epidiolex), a purified marijuana product, was the first.

View Expanded Table: Some Biologic Drugs and JAK Inhibitors for Rheumatoid Arthritis

Rozanolixizumab-noli (Rystiggo – UCB), a neonatal Fc receptor (FcRn) blocker, has been approved by the FDA for treatment of generalized myasthenia gravis in adults with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. It is the first drug to be approved for treatment of generalized myasthenia gravis in patients with anti-MuSK antibodies. Four other biologic drugs – the FcRn blocker efgartigimod alfa (Vyvgart; Vyvgart Hytrulo) and the complement inhibitors eculizumab (Soliris), ravulizumab (Ultomiris), and zilucoplan (Zilbrysq) – are...

An FDA panel has recommended that stronger warnings about hepatotoxicity be added to the labeling for acetaminophen (www.fda.gov, search "acetaminophen hepatotoxicity").

The FDA has approved delafloxacin (Baxdela – Melinta), an anionic fluoroquinolone antibiotic, for oral and parenteral treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is the first fluoroquinolone to be approved for treatment of MRSA.

Six years after an FDA advisory committee recommended development of a combination tablet containing an oral contraceptive and folic acid,1 the FDA has approved Beyaz (Bayer), a combination of the oral contraceptive Yaz2 with 451 mcg of levomefolate calcium, the primary metabolite of folic acid.3 According to the FDA, an unpublished double-blind, randomized U.S. trial in 379 healthy women 18-40 years old found that the combination increased serum folate levels. In an unpublished German study using a similar oral contraceptive/ levomefolate combination (summarized in the package insert), folate...

Fungal infections of the fingernails or toenails can persist for months or years despite topical and systemic antimicrobial therapy. The FDA has cleared several short-pulse laser systems for treatment of this mainly cosmetic disorder.