The FDA has recently approved 2 new drugs for treatment of chronic hepatitis C virus (HCV) infection. Simeprevir (Olysio – Janssen) is the third oral protease inhibitor to be approved for use in combination with peginterferon and ribavirin for treatment of chronic HCV genotype 1 infection in adults with compensated liver disease. Telaprevir (Incivek) and boceprevir (Victrelis) were approved in 2011 for the same indication. Sofosbuvir (Sovaldi – Gilead), a nucleotide analog polymerase inhibitor that has been approved for use with and without interferon for treatment of multiple HCV...

The FDA has approved an intranasal gel formulation of testosterone (Natesto – Trimel/Endo) for replacement therapy in men with hypogonadism. Packaged in a metered-dose pump, Natesto is the first intranasal testosterone to become available in the US. Like other testosterone products, it is classified as a schedule III controlled substance. The FDA recently cautioned against using testosterone to treat low testosterone levels solely due to aging because the benefits and safety of such use have not been established, and there is a possible increased risk of myocardial infarction...

The FDA has approved the human interleukin (IL)-12 and -23 antagonist ustekinumab (Stelara – Janssen Biotech) for treatment of moderately to severely active Crohn's disease in adults who were intolerant of or whose disease was unresponsive to treatment with immunomodulators or corticosteroids, or a tumor necrosis factor (TNF) inhibitor. Ustekinumab was approved earlier for treatment of psoriasis and psoriatic arthritis.

The FDA has approved betrixaban (Bevyxxa – Portola), a once-daily, oral, direct factor Xa inhibitor, for prophylaxis of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness who have moderately or severely restricted mobility and other risk factors for VTE. Betrixaban is the first oral anticoagulant to be approved in the US for this indication.

The FDA has warned that use of the macrolide antibiotic clarithromycin (Biaxin, and generics) may increase the risk of cardiovascular morbidity and mortality in patients with heart disease.

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 deucravacitinib (Sotyktu – BMS), an oral tyrosine kinase 2 (TYK2) inhibitor, for once-daily treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Deucravacitinib is the first selective TYK2 inhibitor to be approved in the US for any indication.

Phosphonoformic acid or foscarnet (Foscavir - Astra), a synthetic antiviral drug, has now been approved by the US Food and Drug Administration for intravenous (IV) treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. CMV retinitis occurs in up to 30% of patients with AIDS and often causes blindness (MD de Smet and RB Nussenbatt, JAMA, 266:3019, Dec 4, 1991).

Carnitine is a naturally occurring amino acid derivative essential for transport of long-chain fatty acids into mitochondria. It is advertised on the Internet as a dietary supplement that can promote weight loss, increase energy, enhance athletic performance and slow aging. Levocarnitine (Carnitor - Sigma-Tau) has been FDA approved for oral and parenteral treatment of primary carnitine deficiency since 1986. Products containing levocarnitine and its synthetic derivative acetyl-L-carnitine are available as dietary supplements in the US.

Levalbuterol, the R-isomer of the beta-2 adrenergic agonist albuterol, is now available in the US as a metered-dose inhaler (Xopenex HFA - Sepracor) for treatment of asthma in patients ≥ 4 years old. Levalbuterol has been available since 1999 in a nebulizer solution for treatment of bronchospasm in patients ≥ 6 years old.1 Outside the US, albuterol is called salbutamol, and levalbuterol is levosalbutamol.