The FDA has approved a sumatriptan iontophoretic transdermal system (Zecuity – Teva) for acute treatment of migraine in adults. Sumatriptan, the first of seven serotonin receptor antagonists (triptans) approved for this indication, is the most frequently prescribed migraine treatment in the US. It is also available in oral, intranasal, and injectable formulations.

The FDA has approved a rapidly disintegrating tablet formulation of the antiepileptic drug levetiracetam (Spritam – Aprecia) for adjunctive treatment of partialonset, myoclonic, and primary generalized tonicclonic seizures. Oral and intravenous formulations of levetiracetam (Keppra, and generics) have been available for years. Although approved by the FDA only as adjunctive therapy, levetiracetam is commonly used as monotherapy for partial-onset and generalized seizures and may also be effective in treating absence seizures and seizures of Lennox-Gastaut syndrome.

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.

Fruquintinib (Fruzaqla – Takeda), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, in patients with RAS wild-type mutations, anti-EGFR therapy. The drug can be used in patients with mCRC regardless of biomarker status. Fruquintinib is the first drug to become available in the US for treatment of mCRC that targets 3 VEGF receptor kinases.

Marstacimab-hncq (Hympavzi – Pfizer), a tissue factor pathway inhibitor (TFPI) antagonist, has been approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients ≥12 years old who have hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors. It is the first hemophilia treatment to be approved in the US that targets an inhibitor of coagulation and the first to become available in prefilled pens and syringes for subcutaneous administration.

A recent Medical Letter article reported renewed interest in the intranasal administration (off-label) of the opioid antagonist naloxone because of an increase in deaths from opioid overdose in the US.1 Now the FDA has approved a more practical alternative for emergency treatment of life-threatening opioid overdose in adults and children: a single-dose naloxone auto-injector (Evzio – Kaleo) for intramuscular or subcutaneous use.Evzio will be available in kits containing two prefilled 0.4-mg auto-injectors with voice guidance and a "trainer" device that also has voice guidance, but does not...

Pipecuronium bromide (Arduan - Organon), a long-acting, non-depolarizing neuromuscular agent chemically related to pancuronium (Pavulon; and others), is now available in the USA for use as a skeletal muscle relaxant during general anesthesia and for endotracheal intubation. It is not recommended for procedures that last less than 90 minutes or for patients requiring prolonged mechanical ventilation in intensive care units.

Masoprocol cream 10% (meso-nordihydroguiaretic acid, Actinex - Reed and Carnrick) is now available in the USA for topical treatment of actinic keratoses.

Brinzolamide (Azopt - Alcon), a thieno-thiazine-6-sulfonamide carbonic anhydrase inhibitor, has been approved by the FDA in a 1% ophthalmic suspension for treatment of elevated intraocular pressure due to ocular hypertension or open-angle glaucoma. Brinzolamide is the second FDA-approved topical carbonic anhydrase inhibitor. Dorzolamide (Trusopt) was approved earlier (Medical Letter, 37:76, 1995).

Valrubicin (Valstar), formerly known as AD 32, has been approved by the FDA for intravesical treament of bladder cancer. The approval is limited to patients with carcinoma-in-situ refractory to BCG for whom immediate cystectomy is contraindicated.