Ashwagandha is an herb extracted from the roots of an evergreen shrub (Withania somnifera) found in India that has been used as a "tonic" for centuries. No specific constituent has been identified as an active ingredient. Herbal supplements containing ashwagandha, which is also known as winter cherry and Indian ginseng, are widely promoted now in the US for treatment of pain, anxiety, stress, fatigue, sleep disturbances, cognitive decline, diabetes, arthritis, male infertility, and various cancers.

Retapamulin (re-tap'-a-mue'-lin; Altabax - Glaxo SmithKline) is a topical antibiotic recently approved by the FDA for treatment of bullous and non-bullous impetigo due to Streptococcus pyogenes and methicillin-susceptible Staphylococcus aureus. It is available as a 1% ointment by prescription only.

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...

Alzheimer's disease (AD) is the most common cause of dementia, but cognitive decline is also associated with other neurological conditions such as Parkinson's disease, dementia with Lewy bodies, vascular dementia, and frontotemporal dementia.

Ciprofloxacin, previously available orally (Cipro - Medical Letter, 30:11, 1988) and for ophthalmic use (Ciloxan - Medical Letter, 33:52, May 31, 1991), is now the first fluoroquinolone antibiotic to become available in the USA in an intravenous (IV) formulation. Cipro I.V. (Miles) is being promoted as an alternative to third-generation cephalosporins, aminoglycosides, and other drugs used for treatment of serious infections.

Naltrexone (ReVia -DuPont Pharma), a long-acting oral opioid antagonist previously marketed for treatment of opioid dependence under the trade name Trexan, was recently approved by the US Food and Drug Administration (FDA) for treatment of alcohol dependence. The new trade name will now also be used for the old indication.

The FDA has approved two new oral kinase inhibitors for treatment of unresectable or metastatic melanoma: dabrafenib (Tafinlar – GSK) for melanomas with BRAF V600E mutations and trametinib (Mekinist – GSK) for melanomas with either BRAF V600E or V600K mutations. Dabrafenib is not recommended for patients with wild-type BRAF (BRAF-negative) melanoma, and trametinib is not recommended for patients who have received prior BRAF-inhibitor therapy.

Deflazacort (Emflaza – PTC Therapeutics), an oral corticosteroid, has been approved by the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients ≥5 years old. It has been available outside the US for many years. Deflazacort is the second drug to be approved for treatment of DMD; eteplirsen (Exondys 51), an antisense oligonucleotide approved for IV administration in patients with mutations of the dystrophin gene amenable to exon 51 skipping (about 13% of DMD cases), was the first.

Maribavir (Livtencity – Takeda), an oral cytomegalovirus (CMV) pUL97 kinase inhibitor, has been approved by the FDA for treatment of post-transplant CMV infection refractory to standard antiviral therapy in patients ≥12 years old who weigh at least 35 kg.

The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have received accelerated approval by the FDA for use together for a fifth indication: treatment of unresectable or metastatic solid tumors with a BRAF V600E mutation in patients ≥6 years old who have progressed following prior treatment and have no satisfactory alternative treatment options. The combination is not approved for treatment of colorectal cancer because of known intrinsic resistance to BRAF inhibition and dabrafenib is not approved for use in patients with wild-type BRAF...