The FDA has approved a 0.75% ophthalmic solution of the alpha-adrenergic antagonist phentolamine (Ryzumvi – Viatris) for treatment of mydriasis produced by adrenergic agonists such as phenylephrine or parasympatholytic agents such as tropicamide in patients ≥3 years old. Ryzumvi is the first drug to be approved in the US for reversal of pharmacologically induced mydriasis.

Inavolisib (Itovebi – Genentech), an oral kinase inhibitor, has been approved by the FDA for use in combination with palbociclib and fulvestrant for treatment of endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. This is the first approval for Itovebi; palbociclib and fulvestrant have been available for years for treatment of HR-positive, HER2-negative breast cancer.

Two new fixed-dose combinations are now available for management of type 2 diabetes. Metaglip (Bristol-Myers Squibb), a combination of metformin and glipizide, is approved for initial therapy or as second-line treatment when control is not adequate on metformin or a sulfonylurea alone. Avandamet (GlaxoSmithKline), a combination of metformin and rosiglitazone, is approved by the FDA only as second-line therapy for patients who are not well controlled on metformin alone, or are already taking both metformin and rosiglitazone. Glucovance (Bristol-Myers Squibb), a combination of metformin and...

Gabapentin (Neurontin - Pfizer), which has been available in the US since 1994, is approved by the FDA only for treatment of partial epilepsy and postherpetic neuralgia, but is widely used off-label for a number of other indications, especially neuropathic pain syndromes. According to one report, among Medicaid recipients in Florida receiving gabapentin, 71% of prescriptions were for chronic pain and 8% for seizures and neuralgia ("The Pink Sheet" February 2, 2004; 66:30).

Azacitidine (Vidaza - Pharmion), a pyrimidine nucleoside analog of cytidine, is the first drug approved by the FDA for treatment of myelodysplastic syndrome (MDS). Azacitidine is incorporated into newly synthesized DNA and inhibits DNA methyltransferase. Hypomethylation of DNA can restore the normal expression of genes critical for cell differentiation.

The FDA has approved ThermaClear (Therative), a battery-powered, handheld device, to treat individual acne lesions with heat. ThermaClear is indicated only for use on mild to moderate inflammatory acne, not severe nodular or severe cystic acne, and it is not meant to be used on blackheads and whiteheads. Two similar devices are already on the market: Zeno, another handheld device that delivers heat to acne lesions, and the Radiancy Clear Touch Lite Acne Clearance System, a larger heat-delivery device.

Tetrabenazine (Xenazine - Ovation Pharmaceuticals), an old drug first synthesized 50 years ago for treatment of schizophrenia, was recently approved by the FDA for the treatment of chorea associated with Huntington's disease. It has been available in other countries for decades.

The FDA has approved benzyl alcohol lotion, 5% (Ulesfia Lotion - Sciele) for treatment of head lice in patients ≥6 months old. The active ingredient is 5% benzyl alcohol; the vehicle is 5% mineral oil.

The FDA has approved the use of ustekinumab (Stelara - Centocor Ortho Biotech), an interleukin antagonist given by subcutaneous (SC) injection for treatment of adults with moderate to severe plaque psoriasis. It is the first agent in its class for this indication; the other biologic agents for psoriasis are Tcell or tumor necrosis factor (TNF) inhibitors.

Telaprevir (Incivek – Vertex) and boceprevir (Victrelis – Merck) have been approved by the FDA for oral use in combination with peginterferon and ribavirin for treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adults with compensated liver disease. Both telaprevir and boceprevir were developed specifically to inhibit the NS3/4A proteases that cleave HCV encoded polyproteins of the genotype 1 virus.