The FDA has approved perfluorohexyloctane ophthalmic solution (Miebo – Bausch+Lomb) for treatment of dry eye disease. Available only by prescription, Miebo is the first ophthalmic product to be approved in the US that specifically targets tear evaporation caused by meibomian gland dysfunction. An ophthalmic solution with a similar name, Meibo Tears (Vista), which contains 0.6% propylene glycol, is available over the counter for dry eye relief.

The FDA has approved mannitol powder for oral inhalation (Bronchitol – Chiesi) as add-on maintenance treatment to improve pulmonary function in adults with cystic fibrosis (CF). This product has been available in Europe for the same indication since 2012. Another formulation of mannitol inhalation powder (Aridol) is approved in the US for assessment of bronchial hyperresponsiveness.

The FDA has approved Kimyrsa (Melinta), a new IV formulation of the long-acting lipoglycopeptide antibiotic oritavancin, for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria. Orbactiv (Melinta), another IV formulation of oritavancin, was approved in 2014 for the same indication. Kimyrsa has a smaller infusion volume (250 mL vs 1 L) and a shorter infusion time (1 hour vs 3 hours) compared to Orbactiv (see Table 1).

The FDA has approved a fixed-dose combination of the amide local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam as an extended-release (ER) solution (Zynrelef – Heron) for single-dose, intraoperative, soft-tissue or periarticular instillation to provide postsurgical analgesia for up to 72 hours in adults undergoing foot and ankle, small-to-medium open abdominal, or lower extremity total joint arthroplasty surgical procedures.

The FDA has issued an Emergency Use Authorization (EUA) for Lilly's investigational monoclonal antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) to be administered together for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease and/or hospitalization (see Table 1). Bamlanivimab received an EUA for use as monotherapy in such patients in November 2020. Regeneron's investigational monoclonal antibodies casirivimab (REGN10933) and imdevimab (REGN10987) are also authorized for use...

The FDA has issued an Emergency Use Authorization (EUA) for a lower-strength (10 mcg/0.2 mL) formulation of the mRNA-based COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) for use in children 5-11 years old. The original formulation of (Comirnaty) (30 mcg/0.3 mL) is FDA-licensed for use in persons ≥16 years old and available under an EUA for use in adolescents 12-15 years old.

Initial treatment of allergic rhinitis (AR) depends on the severity of symptoms and whether they are intermittent or persistent (see Table 1).

The FDA has approved Dextenza (Ocular Therapeutix), a dexamethasone ophthalmic insert, for treatment of ocular itching associated with allergic conjunctivitis. Dextenza was approved earlier for treatment of ocular inflammation and pain following ophthalmic surgery.

The FDA has issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech mRNA-based vaccine for prevention of COVID-19 in persons ≥16 years old.

The FDA has approved evinacumab-dgnb (Evkeeza – Regeneron), an angiopoietin-like 3 (ANGPTL3) inhibitor, for adjunctive IV treatment of homozygous familial hypercholesterolemia (HoFH) in patients ≥12 years old. Evinacumab is the first ANGPTL3 inhibitor to be approved in the US.