News about recent price increases for EpiPen and EpiPen Jr (Mylan) may have patients asking about other options for emergency treatment of anaphylaxis. Adrenaclick and its generic equivalent (epinephrine injection auto-injector) are the only other epinephrine auto-injectors currently available in the US. According to Impax (the manufacturer of both the brand and generic products), Adrenaclick is no longer being manufactured; the generic product will continue to be marketed after supplies of Adrenaclick are depleted. Auvi-Q (Sanofi), an epinephrine auto-injector that was approved by the FDA in...

The FDA has required a new boxed warning in the label of the subcutaneously injected immunomodulatory drug glatiramer acetate (Copaxone, Glatopa, and generics) about a risk of anaphylaxis. Glatiramer has been used for years to treat relapsing forms of multiple sclerosis (MS).

Mivacurium chloride (Mivacron - Burroughs-Wellcome), a short-acting nondepolarizing neuromuscular blocking drug, is now available in the USA for intravenous use in routine intubation and short procedures requiring skeletal muscle relaxation. It can be given in a bolus or a continuous infusion.

Six years after an FDA advisory committee recommended development of a combination tablet containing an oral contraceptive and folic acid,1 the FDA has approved Beyaz (Bayer), a combination of the oral contraceptive Yaz2 with 451 mcg of levomefolate calcium, the primary metabolite of folic acid.3 According to the FDA, an unpublished double-blind, randomized U.S. trial in 379 healthy women 18-40 years old found that the combination increased serum folate levels. In an unpublished German study using a similar oral contraceptive/ levomefolate combination (summarized in the package insert), folate...

The FDA has approved crofelemer (kroe fel’ e mer; Fulyzaq – Salix), a chloride channel inhibitor derived from the red sap of the South American plant Croton lechleri, for symptomatic relief of noninfectious diarrhea in patients with HIV taking antiretroviral drugs. It is the first drug approved for relief of antiretroviral-induced diarrhea and the first oral botanical drug approved by the FDA.

The FDA has approved the oral multikinase inhibitor midostaurin (Rydapt – Novartis) for first-line treatment, in addition to standard chemotherapy, of adults with FLT3 (fms-like tyrosine kinase 3) mutation-positive acute myeloid leukemia (AML). About 30% of patients with AML have FLT3 mutations. Midostaurin is also approved as a single agent for treatment of adults with aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, or mast-cell leukemia. In mastocytosis, midostaurin targets mutant c-KIT, not FLT3.In a randomized, double-blind trial, 717...

In a clinical trial conducted by the CDC's Tuberculosis Trials Consortium in collaboration with the NIH-funded AIDS Clinical Trials Group, a new 4-month regimen for treatment of drug-susceptible pulmonary tuberculosis was found to be noninferior to 6 months of standard treatment.

Brexucabtagene autoleucel (Tecartus – Kite) has been approved by the FDA for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). It was previously approved for treatment of relapsed or refractory mantle cell lymphoma. Tecartus is an individualized cellular product prepared from the patients own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. The CAR T-cell immunotherapy tisagenlecleucel (Kymriah) was approved in 2017 for treatment of relapsed or refractory...

Atazanavir (Reyataz - Bristol-Myers Squibb), a new protease inhibitor (PI), and emtricitabine (Emtriva - Gilead), a nucleoside analogue reverse transcriptase inhibitor (NRTI) chemically similar to lamivudine, have been approved by the FDA for treatment of HIV-1 infection. Both are taken once daily, unlike most anti-HIV drugs.

Micafungin sodium (Mycamine - Astellas), the second echinocandin antifungal to become available in the US, has been approved by the FDA for intravenous treatment of esophageal candidiasis and prophylaxis of invasive Candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT).