Auvi-Q (Kaléo; previously manufactured and marketed by Sanofi), the epinephrine auto-injector approved by the FDA in 2012 for emergency treatment of anaphylaxis and voluntarily withdrawn in 2015 due to potential inaccurate dosage delivery, has become available once more. According to Kaléo, improvements in the manufacturing process have addressed the concerns that led to its recall.

View the Expanded Table: Antibiotics for Travelers' Diarrhea

The short-acting formulation of mixed amphetamine salts (Adderall, and generics) FDA-approved for treatment of attention-deficit hyperactivity disorder (ADHD) and narcolepsy, is currently in short supply in the US. Until an adequate supply is restored, patients may be looking for alternatives.

Efbemalenograstim alfa-vuxw (Ryzneuta – Evive), a nonpegylated granulocyte colony-stimulating factor (G-CSF) conjugated to an Fc fragment of human IgG2, has been approved by the FDA to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive chemotherapy that can cause clinically significant febrile neutropenia. It is the first nonpegylated, long-acting G-CSF to become available in the US. Two pegylated, long-acting G-CSFs, pegfilgrastim (Neulasta, and biosimilars) and eflapegrastim (Rolvedon), are...

Zenocutuzumab (Bizengri – Merus), a bispecific HER2- and HER3-directed antibody, has received accelerated approval from the FDA for treatment of advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion in adults who had disease progression on or after prior systemic therapy. It is the first drug to be approved in the US for treatment of NRG1-positive cancers. Accelerated approval of zenocutuzumab was based on the overall response rate and duration of response.

Zanidatamab-hrii (Ziihera – Jazz), a bispecific HER2-directed antibody, has received accelerated approval from the FDA for treatment of unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer in patients who received prior therapy. Biliary tract cancer includes gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma. Zanidatamab is the first dual HER2-targeted therapy to be approved in the US for this indication. Accelerated approval was based on the overall response rate and duration of response.

The FDA has required a new warning in the labels of the recombinant respiratory syncytial virus (RSV) vaccines Arexvy (GSK) and Abrysvo (Pfizer) about an increased risk of Guillain-Barré syndrome (GBS) within 42 days of administration of either vaccine. Both vaccines are FDA-approved to prevent lower respiratory tract disease (LRTD) caused by RSV in adults.Abrysvo is also approved for use in pregnant women at 32-36 weeks' gestation to prevent RSV-associated LRTD in their infants from birth through 6 months of age.

Qualaquin, the only formulation of quinine sulfate available in the US, is approved only for treatment of uncomplicated malaria, but most prescriptions for its use are written for treatment or prevention of nocturnal leg cramps. The FDA recently issued a warning about its safety.Between April 2005 and October 2008, 38 cases of serious or life-threatening adverse effects of quinine were reported to the FDA. Twenty-one of these patients had thrombocytopenia and required hospitalization. Two deaths were reported: one from hemolysis and the other from thrombotic thrombocytopenic purpura (TTP)....

A recent editorial in The New England Journal of Medicine commented on the negative results of a clinical trial (published in the same issue) of nesiritide, a drug that had been approved by the FDA in 2001 (conditionally approved by Health Canada in 2007) for relief of dyspnea in patients with acutely decompensated heart failure. The authors of the recent clinical trial concluded: "On the basis of these results, nesiritide cannot be recommended for routine use in the broad population of patients with acute heart failure."1 The editorialist lamented the inadequacy of the data that had led to...

The FDA has warned that the IV emulsion formulation of the substance P/neurokinin 1 (NK1) receptor antagonist rolapitant (Varubi) has been associated in postmarketing reports with serious hypersensitivity reactions including anaphylaxis and anaphylactic shock.1 Rolapitant was approved by the FDA as an oral tablet in 2015 for adjunctive prevention of delayed nausea and vomiting associated with cancer chemotherapy in adults2; the IV emulsion formulation of the drug was approved for the same indication in 2017.The reported hypersensitivity reactions occurred during or shortly after infusion of...