The injectable glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide (Zepbound) has been approved by the FDA for treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity. It is the first drug to be approved in the US for this indication. Zepbound is also approved for chronic weight management in adults with obesity and in those who are overweight and have at least one weightrelated comorbidity. Tirzepatide is also available as Mounjaro for treatment of type 2 diabetes.

Dofetilide (Tikosyn - Pfizer), a new methanesulfonamide antiarrhythmic drug, has recently been marketed for oral treatment of atrial fibrillation and flutter.

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...

A combination of the corticosteroid mometasone furoate (Asmanex) and the long-acting beta₂-agonist (LABA) formoterol (Foradil) has become available in a single metered-dose inhaler (Dulera – Schering) for treatment of asthma in patients ≥12 years old. It is the third corticosteroid/LABA combination inhaler to become available for this indication in the US. None of these combinations should be used for initial treatment of asthma or for acute treatment of asthma symptoms.

View the Comparison Table: H2-Receptor Antagonists and PPIs

The FDA has approved the nitrofuran antiprotozoal drug nifurtimox (Lampit – Bayer) for treatment of Chagas disease (American trypanosomiasis) in children who weigh ≥2.5 kg. Nifurtimox was previously available in the US only through a CDC-sponsored Investigational New Drug (IND) program.

The FDA has approved azithromycin 1% ophthalmic solution (AzaSite - Inspire) for treatment of bacterial conjunctivitis in patients > 1 year old. It is formulated, according to the manufacturer, in a controlled-release delivery system that keeps the drug in the eye for several hours.

The FDA has approved the interleukin (IL)-23 blocker guselkumab (Tremfya – Janssen) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Guselkumab is the first selective IL-23 blocker to become available in the US.

The dopamine agonist pramipexole (Mirapex - Boehringer Ingelheim) is the second drug approved by the FDA for treatment of moderate to severe restless legs syndrome (RLS). Ropinirole (Requip), another dopamine agonist, was approved for RLS in 2005. Both of these drugs were first approved for treatment of Parkinson's disease.

Doripenem (Doribax - Ortho-McNeil Janssen), an intravenous (IV) carbapenem antibiotic with a spectrum of activity similar to that of imipenem and meropenem, has been approved by the FDA for treatment of complicated intra-abdominal and urinary tract infections. Use of doripenem for treatment of nosocomial pneumonia, including ventilator-associated pneumonia, is still under FDA review.