The FDA has approved levomilnacipran (lee" voe mil na' si pran; Fetzima – Forest), a serotonin and norepinephrine reuptake inhibitor (SNRI), for treatment of major depressive disorder. Levomilnacipran is the more active enantiomer of milnacipran (Savella), which was approved in 2009 for management of fibromyalgia. Fetzima has not been studied in fibromyalgia.

The FDA has approved miltefosine (Impavido – Knight Therapeutics), an oral alkylphosphocholine analog, for treatment of visceral, cutaneous, and mucosal leishmaniasis caused by some Leishmania species. It is the first drug to be approved by the FDA for treatment of cutaneous and mucosal leishmaniasis and the first oral drug to be approved for treatment of visceral leishmaniasis.

View the Comparison Table: Some Parenteral Anticoagulants for VTE

The FDA has approved margetuximab-cmkb (Margenza – MacroGenics), a HER2/neu receptor antagonist, for use in combination with chemotherapy for treatment of metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2 regimens, at least one of which was for metastatic disease.

Adagrasib (Krazati – Mirati Therapeutics), a RAS GTPase family inhibitor, has received accelerated approval from the FDA for oral treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the objective response rate and duration of response.

Balfaxar (Octapharma), a human plasma-derived four-factor prothrombin complex concentrate (PCC), has been approved by the FDA for rapid reversal of warfarin anticoagulation in adults who require an urgent surgical/invasive procedure. It is the second four-factor PCC to become available in the US; Kcentra, which has been available since 2013, is approved for the same indication and for urgent reversal of warfarin anticoagulation in adults with acute major bleeding. Balfaxar is marketed in Canada and Europe as Octaplex.

The FDA has approved vutrisiran (Amvuttra – Alnylam), a subcutaneously injected small interfering RNA (siRNA), to reduce cardiovascular hospitalizations, urgent heart failure visits, and cardiovascular death in adults with wild-type or variant transthyretin amyloid cardiomyopathy (ATTR-CM). Vutrisiran is the first siRNA to be approved in the US for this indication; it was approved earlier for treatment of polyneuropathy associated with hereditary transthyretin-mediated amyloidosis.

Acute toxic reactions to drugs of abuse continue to be important problems. Some patients may have mixed intoxications with complex combinations of signs and symptoms.

Nexplanon (Merck), a modified version of the contraceptive implant Implanon (Merck), is now available in the US. Nexplanon contains 68 mg of the progestin etonogestrel and is bioequivalent to Implanon. Both products are single-rod subdermal contraceptives implanted into the inside of the upper arm; both provide reversible effective contraception for up to 3 years.1 Nexplanon has a redesigned preloaded applicator intended to make insertion easier and reduce the risk of improperly placed devices. Proper placement is necessary to ensure adequate contraceptive efficacy and to facilitate future...

The FDA has approved asparaginase Erwinia chrysanthemi (Erwinaze – EUSA), an asparagine-specific enzyme derived from the gram-negative bacillus Erwinia chrysanthemi, for use in combination with other chemotherapeutic agents for treatment of acute lymphoblastic leukemia (ALL) in patients who have had allergic reactions to Escherichia coli-derived asparaginase (Elspar or pegaspargase [Oncaspar]).ALL is the most common malignancy of childhood. Multidrug chemotherapy can cure about 80% of children with ALL.1 Initial treatment ("induction") usually includes vincristine, a glucocorticoid, and an...