Diclofenac epolamine patch 1.3% (Flector Patch - Alpharma), a topical formulation of the nonsteroidal anti-inflammatory drug (NSAID) diclofenac, has been approved by the FDA for topical treatment of acute pain due to minor strains, sprains and contusions. It is the first topical NSAID patch approved in the US. A diclofenac patch has been used in Europe since 1993. Diclofenac sodium (Voltaren, and others) is available in the US as an oral tablet, in a 1% gel for treatment of osteoarthritis (to be reviewed in a future issue), in a 3% gel (Solaraze) for treatment of actinic keratoses, and in an...

The FDA has approved the marketing of fingolimod (Gilenya – Novartis) to reduce the frequency of clinical exacerbations and delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis (MS). Fingolimod is the first oral drug approved for this indication.

The FDA recently approved the marketing of hydroxyprogesterone caproate injection (Makena – Ther-Rx) for prevention of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

The FDA has approved rivaroxaban (Xarelto – Janssen), an oral direct factor Xa inhibitor, for prevention of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery.

The FDA has approved ingenol mebutate (Picato – Leo) for topical treatment of actinic keratoses (AKs). The new drug is derived from the sap of the Euphorbia peplus plant, a traditional folk remedy for warts and other skin lesions.

The FDA has approved a once-daily, extended-release oral suspension of methylphenidate (Quillivant XR – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the first liquid formulation of the drug to be marketed for once-daily use. A short-acting oral solution (Methylin, and generics) has been available since 2003.

The FDA has approved dimethyl fumarate (Tecfidera – Biogen Idec), formerly called BG-12, for treatment of relapsing forms of multiple sclerosis (MS). It is the third oral drug to be approved in recent years for this indication.

The anthracycline doxorubicin with or without the alkylating agent ifosfamide is the standard first-line treatment for advanced soft-tissue sarcomas. The FDA recently approved the minor groove DNA intercalator trabectedin (Yondelis – Janssen) for treatment of unresectable or metastatic liposarcoma or leiomyosarcoma in patients previously treated with an anthracycline. Trabectedin has been available for years in Europe for treatment of advanced soft-tissue sarcoma. The FDA has also approved the microtubule inhibitor eribulin mesylate (Halaven – Eisai), which was approved earlier for...

The FDA has approved sugammadex (Bridion – Merck), a selective relaxant binding agent, for reversal of rocuronium- or vecuronium-induced neuromuscular blockade in adult surgical patients. It is the first selective relaxant binding agent to be approved in the US. Sugammadex has been available in the European Union, Japan, and elsewhere for several years. Previous FDA reviews of sugammadex did not result in approval because of concerns about a risk of anaphylaxis and other hypersensitivity reactions with its use.

The investigational monoclonal antibody sotrovimab (VIR-7831; GSK/Vir Biotechnology) has been granted an FDA Emergency Use Authorization (EUA) for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease, including hospitalization and death.1 Two other monoclonal antibody regimens are authorized for the same indication: casirivimab (REGN10933) and imdevimab (REGN10987) administered together, and bamlanivimab (LY-CoV555) and etesevimab (LYCoV016) administered together. The FDA revoked its EUA...