Valacyclovir (Valtrex - Glaxo Wellcome), an L- valyl ester of acyclovir (Zovirax), has been approved by the US Food and Drug Administration (FDA) for oral treatment of herpes zoster (shingles) in immunocompetent adults. Famciclovir (Famvir - Medical Letter, 36:97, 1994) is also available for this indication.

Reteplase (Retavase - Boehringer Mannheim), a recombinant protein derivative of human tissue plasminogen activator (t-PA), has been marketed in the USA for thrombolysis in patients with acute myocardial infarction.

Samarium-153 lexidronam (Quadramet - Dupont Pharma) has been approved by the FDA for relief of pain in patients with osteoblastic bone metastases. Strontium-89 (Metastron) has been available for several years for this indication (Medical Letter, 35:102, 1993).

The angiotensin receptor blocker (ARB) azilsartan medoxomil (Edarbi – Takeda) was recently approved by the FDA for oral treatment of hypertension, either alone or combined with other drugs. It is the eighth ARB approved for this indication.

The FDA has approved a new extended-release formulation of the corticosteroid budesonide (Uceris – Santarus) for induction of remission in patients with mild to moderate ulcerative colitis.

Tiotropium bromide, an inhaled long-acting anticholinergic available since 2004 as a dry powder inhaler (Spiriva Handihaler) for once-daily treatment of chronic obstructive pulmonary disease (COPD), has now also been approved in an inhalation spray formulation (Spiriva Respimat – Boehringer Ingelheim). According to the manufacturer, the Respimat device improves delivery of tiotropium to the lungs because, unlike with the Handihaler, it is not dependent on the strength of the patient’s breath intake.

The FDA has approved filgrastim-sndz (Zarxio – Sandoz), a biosimilar of the recombinant human granulocyte colony-stimulating factor filgrastim (G-CSF; Neupogen), which has been available in the US since 1991. Zarxio is the first biosimilar product to be approved in the US; it has been available in Europe as Zarzio since 2009.

The FDA has approved sebelipase alfa (Kanuma – Alexion), a recombinant form of lysosomal acid lipase (LAL), for enzyme replacement therapy in patients with LAL deficiency. Sebelipase alfa is the first drug to be approved in the US for treatment of LAL deficiency, a rare autosomal recessive storage disease.

The FDA has approved cemiplimab-rwlc (Libtayo – Regeneron), an immune checkpoint inhibitor, for use in combination with platinum-based chemotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS1 aberrations and who are not candidates for surgical resection or chemoradiation. The drug was previously approved for first-line treatment of NSCLC in patients whose tumors have high PD-L1 expression and no genomic tumor aberrations....

Isatuximab-irfc (Sarclisa – Sanofi), a CD38-directed cytolytic antibody, has been approved by the FDA for treatment of newly diagnosed multiple myeloma in adults who are not eligible for autologous stem cell transplantation (ASCT). The drug was approved earlier for treatment of relapsed or treatment-refractory multiple myeloma.