The FDA has approved Merilog (Sanofi), a biosimilar to rapid-acting insulin aspart (NovoLog), for treatment of patients with type 1 or type 2 diabetes. Merilog is the first rapid-acting insulin biosimilar product to become available in the US.

Endoscopic injection of sclerosing agents is now widely accepted as a primary treatment for bleeding esophageal varices (J Terblanche et al, N Engl J Med, 320:1393, 1469, May 25 and June 1, 1989). Ethanolamine oleate 5% (Ethamolin - Glaxo), a sclerosing agent that has been available in Canada and abroad for many years, was recently approved for this indication by the US Food and Drug Administration (FDA).

BCG Live (TheraCys - Connaught) and BCG Vaccine U.S.P. (TiceBCG - Organon), freeze-dried suspensions of an attenuated strain of Mycobacterium bovis, were recently approved by the US Food and Drug Administration for intravesical treatment of primary or relapsed carcinoma in situ of the bladder, with or without associated papillary tumors. BCG is not recommended for treatment of papillary tumors occurring alone.

The prognosis in breast cancer is generally poor for women with unresectable, locally advanced disease (inflammatory cancer or more than 10 positive lymph nodes) and for those with metastases. Autologous bone marrow transplantation - removing bone marrow from multiple sites under general anesthesia, giving high-dose chemotherapy with or without total body radiation, and reinfusing the bone marrow intravenously - is being tried in some of these patients.

The number of immunizations recommended for infants and young children has increased in recent years with the addition of vaccines to prevent Haemophilus influenzae type b infection and hepatitis B (Medical Letter, 33:5, 1991; 34:69, 1992). Now the US Food and Drug Administration has licensed a new vaccine for infants (Tetramune - Lederle-Praxis) that combines a traditional diphtheria, tetanus, and pertussis vaccine (DTP; Tri-Immunol) with a vaccine against Haemophilus influenzae type b (HibTiter).

The US FDA has approved use of palivizumab for prevention of respiratory syncytial virus (RSV) infection in high-risk infants and children.

Recombinant human α-L-iduronidase (laronidase; Aldurazyme BioMarin/Genzyme), an orphan drug, has been approved by the FDA for enzyme replacement therapy in mucopolysaccharidosis (MPS) type I, a lysosomal storage disorder caused by deficiency of the enzyme. This review describes the disease, treatment, adverse effects and cost.

The Drug Enforcement Administration (DEA) has reclassified all hydrocodone combination products as schedule II controlled substances; they were previously classified as schedule III. Hydrocodone alone (Zohydro ER) is already a schedule II controlled substance.

The FDA has approved Semglee (Mylan), an insulin glargine product similar to Lantus, for treatment of type 1 diabetes in children and adults and type 2 diabetes in adults. Semglee is the second "follow-on" insulin glargine product to become available in the US; Basaglar, which is also similar to Lantus, was the first. Lantus is a recombinant analog of human insulin that forms microprecipitates in subcutaneous tissue, prolonging its duration of action to a mean of about 24 hours with no pronounced peak effect.

Sacituzumab govitecan-hziy (Trodelvy – Gilead) has been approved for treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in adults who received prior endocrine therapy and ≥2 additional systemic therapies for metastatic disease. It was previously approved for treatment-refractory metastatic triplenegative breast cancer and for treatment of locally advanced or metastatic urothelial cancer in adults who received platinum-based chemotherapy and a programmed death receptor-1...