Linagliptin (Tradjenta – Boehringer Ingelheim/Lilly), a third oral dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, was recently approved by the FDA for treatment of type 2 diabetes, either alone or in combination with metformin, a sulfonylurea or pioglitazone

The FDA has approved the interleukin-1 (IL-1) beta inhibitor canakinumab (Ilaris – Novartis) for treatment of systemic juvenile idiopathic arthritis (sJIA; formerly called juvenile rheumatoid arthritis or Still’s disease) in children ≥2 years old. Canakinumab was approved earlier for treatment of cryopyrin-associated periodic syndromes (CAPS). Tocilizumab (Actemra), an interleukin-6 (IL-6) inhibitor that has been available since 2010 for treatment of rheumatoid arthritis in adults, was also recently approved by the FDA for sJIA. Canakinumab is the only IL-1 inhibitor approved...

The FDA has approved vortioxetine (vor" tye ox' e teen; Trintellix – Takeda/Lundbeck), a new serotonergic drug, for treatment of major depressive disorder. Like vilazodone (Viibryd), another serotonergic antidepressant, it has been claimed to have a low incidence of sexual side effects and no significant effect on weight.

The FDA has approved a new 2.5-mg formulation of the direct factor Xa inhibitor rivaroxaban (Xarelto – Janssen) for use in combination with low-dose aspirin to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). Rivaroxaban is the first direct oral anticoagulant to be approved for this indication. It was approved earlier for prevention and treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and for prevention of stroke and systemic embolism in patients with nonvalvular atrial...

A reader has questioned why the label for the COX-2 selective NSAID celecoxib (Celebrex, and generics), which contains a sulfonamide moiety, states that it is contraindicated for use in patients with an allergy to sulfonamides, while the labels of some other sulfonamide drugs recommend either caution or no precautions at all. The concept of cross-reactivity among sulfonamide drugs, particularly between antibacterial and nonantibacterial sulfonamides, has been controversial for many years.

The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use as a second booster dose ≥4 months after a first booster dose in adults ≥50 years old and in persons aged ≥12 years (Pfizer) or ≥18 years (Moderna) who have undergone solid organ transplantation or have a condition that compromises the immune system to a similar extent.

Opdualag (BMS), a fixed-dose combination of two immune checkpoint inhibitors — nivolumab (Opdivo), a programmed death receptor-1 (PD-1) inhibitor, and relatlimab-rmbw, a lymphocyte-activation gene-3 (LAG-3) blocking antibody — has been approved by the FDA for treatment of unresectable or metastatic melanoma in patients ≥12 years old. Relatlimab, which is only available in combination with nivolumab, is the first LAG-3 blocking antibody to become available in the US. Immune checkpoint inhibitors, including the anti-CTLA-4 antibody ipilimumab (Yervoy) and the PD-1 inhibitors...

Toripalimab-tpzi (Loqtorzi – Coherus Biosciences), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin and gemcitabine for first-line treatment of recurrent locally advanced or metastatic nasopharyngeal carcinoma and for use as monotherapy for treatment of recurrent unresectable or metastatic nasopharyngeal carcinoma in adults with disease progression on or after platinum-based chemotherapy. It is the first immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma.

Levocetirizine (Xyzal - UCB/Sanofi-aventis), the active enantiomer of the second-generation H₁-antihistamine cetirizine (Zyrtec), has been approved by the FDA for treatment of seasonal and perennial allergic rhinitis (SAR and PAR) and chronic idiopathic urticaria in adults and children 6 years of age and older. Cetirizine has been approved by the FDA for over-the-counter use and may also become available generically in the US. Levocetirizine has been available in Europe since 2001.

The FDA has approved cariprazine (Vraylar – Actavis), an oral, once-daily, second-generation antipsychotic, for treatment of schizophrenia and for acute treatment of manic or mixed episodes associated with bipolar I disorder.