The FDA has approved taliglucerase alfa (ta lee gloo´ se rays; Elelyso – Pfizer/Protalix), a recombinant form of glucocerebrosidase, for treatment of adults with Type 1 Gaucher disease. These patients have a genetic deficiency of the lysosomal enzyme glucocerebrosidase that leads to accumulation of glucosylceramide in the lysosomes of reticuloendothelial cells, primarily in the liver, spleen and bone marrow.1Taliglucerase is the third form of the enzyme to become available in the US. Imiglucerase (Cerezyme) and velaglucerase (Vpriv) are produced in mammalian cell lines. Taliglucerase is...

A new sublingual tablet formulation of the partial opioid agonist buprenorphine combined with the opioid antagonist naloxone (Zubsolv – Orexo) has been approved by the FDA for maintenance treatment of opioid dependence. Zubsolv tablets have relatively greater bioavailability than previously approved sublingual film (Suboxone) and sublingual tablet formulations of buprenorphine/naloxone and, according to an open-label survey, they taste better. The new tablets are smaller and dissolve faster than other tablet formulations, and they are individually sealed in child-resistant...

The FDA has approved the anti-CD30 antibody-drug conjugate brentuximab vedotin (Adcetris – Seattle Genetics) for use in combination with chemotherapy for IV treatment of adults with previously untreated stage 3 or 4 classical Hodgkin's lymphoma (cHL). Adcetris was approved earlier for consolidation treatment of cHL and for treatment of relapsed or refractory cHL, anaplastic large cell lymphoma, and CD30-expressing mycosis fungoides.FDA approval for the new indication was based on the results of an open-label trial (ECHELON-1) in 1334 patients with previously untreated stage 3 or 4 cHL.1...

The FDA has approved a new 550-mg tablet of rifaximin (Xifaxan – Salix), a minimally absorbed oral antibiotic, to reduce the risk of recurrent hepatic encephalopathy (HE). A 200-mg tablet has been available for treatment of travelers’ diarrhea since 2004.

The FDA has approved a new IV formulation of dantrolene (Ryanodex – Eagle) for prevention and treatment of malignant hyperthermia in adults and children. The new formulation requires fewer vials, less fluid volume, and less time for preparation and administration than other available IV dantrolene products (Dantrium, Revonto).

The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include use of the vaccine as a two-dose primary series in adolescents 12-17 years old. The vaccine was authorized for primary immunization of adults in July 2022.

The possibility that use of mifepristone (Mifeprex, and generics) may be restricted has led to questions about alternatives for medication abortion.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin has been available for years alone (Jardiance – Boehringer Ingelheim) and in combination with metformin (Synjardy) to improve glycemic control in adults with type 2 diabetes. Both products have now been approved for use in children ≥10 years old. Empagliflozin is the second oral drug to become available in the US for treatment of type 2 diabetes in children; metformin has been available since 2000 for this indication. The injectable glucagon-like peptide-1 (GLP-1) receptor agonists liraglutide (Victoza) and...

Omlyclo (omalizumab-igec; Celltrion), a biosimilar product interchangeable with the recombinant anti-IgE monoclonal antibody Xolair, has been approved by the FDA for same indications as Xolair (see Table 1). Omlyclo is the first Xolair biosimilar to be approved in the US.

In Table 1 of our February 1, 2016 article Drugs for Acne (Med Lett Drugs Ther 2016; 58:13), the formulations for Differin, topical adapalene, should have been listed as 0.1% gel, cream, lotion; 0.3% gel (not 3% gel).