Many drugs, mostly imidazole derivatives, are marketed in the USA for topical treatment of vulvovaginal candidiasis (Medical Letter, 33:81, 1991). Recently, fluconazole (Diflucan - Roerig), which is the drug of choice for treatment of oropharyngeal and esophageal candidiasis (Medical Letter, 36:16, 1994), was approved by the US Food and Drug Administration for single-dose oral treatment of .

Botulinum toxin type A has been marketed in the USA since 1989 for treatment of strabismus and blepharospasm and has also been used to treat cervical dystonia and some other muscular disorders.

Epirubicin, an analog of doxorubicin that has been available in Europe and Canada for 15 years, has now been approved by the FDA for adjuvant use after resection of the primary tumor in breast cancer patients with axillary node involvement.

Testing for HIV infection in the US typically has been a two-step process that requires patients to return for results. This review describes two rapid tests currently FDA-approved, OraQuick and Reveal. It includes a table with the cost and characteristics of each test (result time, device type, equipment needed, etc.).

The FDA has approved a manually injected, single-dose, prefilled epinephrine syringe (Symjepi – Adamis/Sandoz) for emergency treatment of anaphylaxis. The new device is approved in 0.3- and 0.15-mg strengths for treatment of patients weighing ≥30 kg and 15 to 30 kg, respectively; only the 0.3-mg strength is currently available. According to Sandoz, Symjepi will be made available first to institutions and later to the retail market.

The FDA has approved glucagon nasal powder (Baqsimi – Lilly) for treatment of severe hypoglycemia in patients ≥4 years old with diabetes. Baqsimi is the first noninjectable glucagon formulation to become available in the US. Injectable glucagon emergency kits (GlucaGen Hypokit, and generic) have been available for years, but they require reconstitution of the lyophilized powder by the caregiver immediately before injection. An injectable glucagon formulation that does not require reconstitution was recently approved by the FDA (Gvoke) and is expected to become available...

Toripalimab-tpzi (Loqtorzi – Coherus Biosciences), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin and gemcitabine for first-line treatment of recurrent locally advanced or metastatic nasopharyngeal carcinoma and for use as monotherapy for treatment of recurrent unresectable or metastatic nasopharyngeal carcinoma in adults with disease progression on or after platinum-based chemotherapy. It is the first immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma.

Zanamivir, a neuraminidase inhibitor taken by inhalation, has been approved by the FDA for treatment of influenza. Oseltamivir phosphate, an oral neuraminidase inhibitor, will probably be approved soon.

The FDA has approved a new extended-release capsule formulation of topiramate (Qudexy XR – Upsher Smith), which can be opened and sprinkled on food for patients who have difficulty swallowing tablets or capsules, for treatment of epilepsy. Qudexy XR was marketed as a branded drug in March 2014 and as a generic drug four months later. An earlier extended-release formulation (Trokendi XR) must be swallowed whole.Trokendi XR is approved for initial monotherapy in patients ≥10 years old with partial-onset seizures or primary generalized tonic-clonic seizures and for adjunctive therapy in...

The FDA has required a new warning in the labels of prescription and over-the-counter products containing nonsteroidal anti-inflammatory drugs (NSAIDs) advising against their use during pregnancy beginning at 20 weeks’ gestation because of a risk of renal dysfunction in the fetus that could lead to low amniotic fluid levels (oligohydramnios) and neonatal renal impairment. NSAID labels previously warned against use of the drugs beginning at 30 weeks' gestation because of a risk for premature closure of the ductus arteriosus and persistent neonatal pulmonary hypertension