The FDA has approved Suflave (Sebela/Braintree), a low-volume polyethylene glycol (PEG)- and sulfate-based product for cleansing of the colon prior to colonoscopy in adults. Other oral colonoscopy preparations available in the US are listed in Table 2. Suflave is marketed as tasting better than other products.

In February 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibodies bamlanivimab and etesevimab (Lilly) for use together to treat mild to moderate COVID-19 in persons ≥12 years old who weigh ≥40 kg and are at high risk of progression to severe disease or hospitalization. The FDA has now expanded this EUA to allow use of the antibodies together for post-exposure prophylaxis of COVID-19 in such persons if they are not fully vaccinated against COVID-19 or are unlikely to have an adequate immune response to full vaccination and have...

The FDA has approved Biktarvy (Gilead), a once-daily, fixed-dose combination of bictegravir, a new integrase strand transfer inhibitor (INSTI), and the nucleoside reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide (TAF), for treatment of HIV-1 infection in adults. The new combination is indicated for use in patients who are antiretroviral-naive or who have been virologically suppressed on a stable antiretroviral regimen for ≥3 months with no history of treatment failure and no known substitutions associated with resistance to any component of the...

The FDA has licensed Penbraya (Pfizer), a pentavalent polysaccharide conjugate meningococcal vaccine, for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W, or Y (MenABCWY) in persons 10-25 years old. Penbraya is the only meningococcal vaccine that contains all five of these serogroups. Two quadrivalent polysaccharide conjugate meningococcal vaccines containing serogroups A, C, W, and Y (MenACWY; Menveo, MenQuadfi) and two meningococcal serogroup B vaccines (MenB; Bexsero, Trumenba) are available in the US (see Table...

Eribulin mesylate (Halaven – Eisai) has been approved by the FDA for treatment of patients with metastatic breast cancer who have previously received at least 2 chemotherapy regimens for metastatic cancer. Prior therapy should have included an anthracycline and a taxane in either an adjuvant or metastatic setting. Other drugs used to treat anthracycline- and taxane-refractory metastatic breast cancer include capecitabine (Xeloda), gemcitabine (Gemzar, and others) and vinorelbine (Navelbine, and others).

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).

View the Vaccination Recommendations for Updated 2024-2025 COVID-19 Vaccines

Tazarotene (taz ar' oh teen, Tazorac - Allergan), an acetylinic retinoid marketed for treatment of psoriasis (Medical Letter 1997; 39:105), is also available as a 0.1% gel and cream for treatment of acne.

Valacyclovir (Valtrex - GlaxoSmithKline) was recently approved by the FDA for one-day oral treatment of patients at least 12 years old with orolabial herpes simplex infections. The drug was previously approved for treatment and suppression of genital herpes and for treatment of herpes zoster (shingles).

At the same time that the FDA announced it was strengthening existing warnings about the risk of acute kidney injury in patients with type 2 diabetes treated with the sodium-glucose co-transporter 2 (SGLT2) inhibitors canagliflozin (Invokana, and others) and dapagliflozin (Farxiga, and others), a study was published showing that the third SGLT2 inhibitor, empagliflozin (Jardiance, and others), slowed the progression of renal dysfunction in patients with type 2 diabetes.