The FDA has approved elagolix (Orilissa – AbbVie), an oral gonadotropin-releasing hormone (GnRH) antagonist, for management of moderate to severe pain associated with endometriosis.

Topiramate (Topamax - Ortho-McNeil) has been approved by the US Food and Drug Administration (FDA) for oral use as an adjunct to other drugs in adult patients with partial seizures. Since this diagnostic category includes the largest number of patients with refractory epilepsy, new drugs with antiepileptic activity are usually tried first for this indication. Topiramate (toe pyre' a mate) is a structurally unique agent chemically related to the D-enantiomer of fructose.

Modafinil (Provigil), a benzhydryl sulfinylacetamide non-amphetamine stimulant that has been used in Europe since 1995, has now been approved by the FDA for treatment of excessive daytime sleepiness associated with narcolepsy.

A high-intensity, narrow-band blue light (ClearLight -Lumenis) approved by the FDA for treatment of moderate inflammatory acne vulgaris has been featured in some stories in fashion magazines. This review describes the etiology and treatment of acne, as well as the mechanism of action, clinical studies, adverse effects, dosage and cost of the drug.

Eslicarbazepine acetate (Aptiom – Sunovion) has been approved by the FDA for adjunctive treatment of partial-onset seizures in adults. New drugs for epilepsy are often approved by the FDA initially only as adjunctive treatment for partial seizures. Eslicarbazepine acetate is a prodrug of eslicarbazepine, which is the S-isomer of the active metabolite of oxcarbazepine. Oxcarbazepine itself is similar to carbamazepine. Both oxcarbazepine and carbamazepine are available generically.

The injectable glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide, which was approved by the FDA as Mounjaro for treatment of type 2 diabetes in 2022, has now been approved as Zepbound (Lilly) for chronic weight management in adults who have a BMI ≥30 kg/m2 or a BMI ≥27 kg/m2 and at least one weight-related comorbidity. The injectable GLP-1 receptor agonists liraglutide (Saxenda) and semaglutide (Wegovy) are approved for chronic weight management in patients ≥12 years...

Itraconazole (Sporanox - Janssen), an oral antifungal triazole that has been available in the USA since 1992 for treatment of deep fungal infections (Medical Letter, 35:7, 1993), is now being marketed for treatment of dermatophyte infections of the toenails, with or without fingernail involvement.

The FDA has approved a fixed-dose combination of lumacaftor and ivacaftor (Orkambi – Vertex) for oral treatment of cystic fibrosis (CF) in patients ≥12 years old who are homozygous for the F508del mutation. About 50% of patients in the US with CF are homozygous for the F508del (also called Phe508del) mutation. This is the first approved indication for lumacaftor; ivacaftor is available alone as Kalydeco for treatment of CF in patients ≥2 years old with other mutations. Orkambi is the first drug to be approved in the US for treatment of patients with the F508del...

The investigational oral antiviral drug molnupiravir (Merck/Ridgeback Biotherapeutics) was granted an FDA Emergency Use Authorization (EUA) on December 23, 2021 for treatment of mild to moderate COVID-19 in outpatients ≥18 years old who are at high risk of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative treatment options are not available or clinically appropriate. Paxlovid (Pfizer), nirmatrelvir copackaged with ritonavir, was granted an EUA on December 22, 2021. The IV antiviral drug remdesivir (Veklury) was approved by the...

The FDA has approved three new once-daily fixed-dose antiretroviral drug combinations for treatment of HIV-1 infection. Symfi and Symfi Lo (Mylan) contain the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz and the nucleoside reverse transcriptase inhibitors (NRTIs) lamivudine and tenofovir disoproxil fumarate (TDF) and were approved as complete antiretroviral regimens. Symfi Lo contains a lower dose of efavirenz than both Symfi and Atripla, a fixed-dose combination of efavirenz, TDF, and the NRTI emtricitabine that was approved in 2006. Cimduo (Mylan), which...