Eteplirsen (Exondys 51 – Sarepta), an antisense oligonucleotide, has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the dystrophin gene that is amenable to exon 51 skipping. It is the first drug to be approved for treatment of DMD.

Fensolvi (Tolmar), a long-acting subcutaneous formulation of the gonadotropin-releasing hormone (GnRH) agonist leuprolide acetate, has been approved by the FDA for treatment of central precocious puberty (CPP) in children ≥2 years old. It is the first formulation of the drug to be approved for SC administration once every 6 months. IM formulations of leuprolide acetate, which are given once monthly or every 3 months, and the GnRH agonists histrelin acetate (Supprelin LA) and triptorelin (Triptodur) have been available for years for treatment of CPP.

Tyrvaya (Oyster Point), a nasal spray formulation of the cholinergic agonist varenicline, has been approved by the FDA for treatment of dry eye disease. It is the first nasal spray to be approved in the US for this indication. An oral formulation of varenicline (Chantix, and generics) has been available for years for smoking cessation.

The FDA has approved cantharidin 0.7% solution (Ycanth – Verrica) for topical treatment of molluscum contagiosum in patients ≥2 years old. Ycanth was the first drug to be approved in the US for this indication. A 10.3% gel formulation of berdazimer (Zelsuvmi), a nitric oxide-releasing agent, has also been approved by the FDA for treatment of molluscum contagiosum (in patients ≥1 year old); it will be reviewed in a future issue.

Rotigotine (Neupro - Schwarz Pharma), a nonergot dopamine agonist in a transdermal patch formulation, was recently approved by the FDA for treatment of early Parkinson's disease (PD).

Etidronate (e ti droe' nate) disodium (Didronel - Norwich Eaton), an oral bisphosphonate available for many years for treatment of Paget's disease (Medical Letter, 20:78, 1978), recently has also been used for treatment of postmenopausal osteoporosis.

Altretamine (Hexalen - US Bioscience; Hexastat - Rh ne-Poulenc in Canada), formerly known only by its chemical name, hexamethylmelamine, was recently approved by the US Food and Drug Administration as a single agent for palliative oral treatment of persistent or recurrent ovarian cancer.

Podofilox 0.5% solution (Condylox - Oclassen) was recently approved by the US Food and Drug Administration for treatment of (condylomata acuminata). The drug requires a prescription, but is labeled for application by the patient. Similar topical solutions previously available for this indication are approved only for application by the physician.

Quinapril (Accupril - Parke-Davis), an angiotensin-converting enzyme (ACE) inhibitor, has been approved by the US Food and Drug Administration (FDA) for treatment of hypertension. ACE inhibitors are now widely used for this indication (Medical Letter, 33:33, 1991).

Ketorolac (kee' toe role ak) tromethamine 0.5%, a nonsteroidal anti-inflammatory drug (NSAID) previously available for parenteral and oral administration (Toradol - Medical Letter, 32:79, 1990), has now been approved for ophthalmic use (Acular - Allergan, Fisons) to relieve itching in seasonal allergic conjunctivitis. NSAIDs decrease prostaglandin concentrations in the eye, which theoretically might contribute to a decrease in itching. Several other NSAIDs are available for ophthalmic use in the USA, but none is marketed for this indication. Flurbiprofen (Ocufen) and suprofen (Profenal) ...