The phosphodiesterase type 5 (PDE5) inhibitor tadalafil (Cialis - Lilly) is now being promoted for once daily treatment of erectile dysfunction. Tadalafil differs from sildenafil (Viagra) and vardenafil (Levitra), the other PDE5 inhibitors marketed for erectile dysfunction in the US, in having a much longer duration of action.

In the past 2 years, the FDA has approved 3 new drugs for prevention or treatment of hereditary angioedema (HAE) in non-pregnant adolescents and adults: the C1 esterase inhibitor Cinryze for prophylaxis and the C1 esterase inhibitor Berinert and the kallikrein inhibitor ecallantide (Kalbitor) for treatment of acute attacks.

The FDA has approved levomilnacipran (lee" voe mil na' si pran; Fetzima – Forest), a serotonin and norepinephrine reuptake inhibitor (SNRI), for treatment of major depressive disorder. Levomilnacipran is the more active enantiomer of milnacipran (Savella), which was approved in 2009 for management of fibromyalgia. Fetzima has not been studied in fibromyalgia.

The FDA has approved miltefosine (Impavido – Knight Therapeutics), an oral alkylphosphocholine analog, for treatment of visceral, cutaneous, and mucosal leishmaniasis caused by some Leishmania species. It is the first drug to be approved by the FDA for treatment of cutaneous and mucosal leishmaniasis and the first oral drug to be approved for treatment of visceral leishmaniasis.

An injectable foam formulation of the sclerosing agent polidocanol (Varithena – Provensis/BTG) has been approved by the FDA for treatment of incompetent veins and visible varicosities of the great saphenous vein system. It is the first foam therapy to be approved for this indication, but polidocanol and other sclerosants have been used for years as foam formulations compounded by physicians. Polidocanol is also available in a liquid formulation (Asclera) to treat smaller veins. Sodium tetradecyl sulfate (Sotradecol) is FDA-approved in a liquid formulation for use in...

Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen), a subcutaneously administered thymic stromal lymphopoietin (TSLP) blocker, has been approved by the FDA for add-on maintenance treatment of severe asthma in patients ≥12 years old. It is the first TSLP blocker to become available in the US and the first biologic drug to be approved for treatment of severe asthma without phenotypic or biomarker limitations.

View the Comparison Table: Some Parenteral Anticoagulants for VTE

The FDA has issued an Emergency Use Authorization (EUA) for an adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax. The vaccine is indicated for use as a two-dose primary series to prevent COVID-19 in adults; it is not authorized for use in children or as a booster dose. Three other COVID-19 vaccines are available in the US for primary immunization of adults; the mRNA vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) are FDA-licensed for this indication, and the adenovirus-based vaccine manufactured by Johnson & Johnson (Janssen) is...

Adagrasib (Krazati – Mirati Therapeutics), a RAS GTPase family inhibitor, has received accelerated approval from the FDA for oral treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the objective response rate and duration of response.

The FDA has approved Verkazia (Santen), a 0.1% ophthalmic emulsion formulation of the calcineurin inhibitor cyclosporine, for treatment of vernal keratoconjunctivitis (VKC). Verkazia is the first product to be approved in the US for this indication.