The FDA has approved daclatasvir (Daklinza – BMS), an oral direct-acting antiviral drug, for use with sofosbuvir (Sovaldi) for treatment of chronic hepatitis C virus (HCV) genotype 3 infection. Daclatasvir is the first drug approved for this indication that does not require the addition of interferon or ribavirin. It is approved in Japan and Europe in combination with other drugs for treatment of HCV genotypes 1-4.

The FDA has approved mepolizumab (Nucala - GSK), a subcutaneously injected humanized interleukin-5 (IL-5) antagonist monoclonal antibody, for maintenance treatment of severe asthma in patients ≥12 years old who have an eosinophilic phenotype.

The FDA has approved the hedgehog pathway inhibitor sonidegib (Odomzo – Novartis) for oral treatment of locally advanced basal cell carcinoma that cannot be treated with surgery or radiation or has recurred following such treatment. Vismodegib (Erivedge), another oral hedgehog pathway inhibitor, was approved earlier for the same indication and also for treatment of metastatic basal cell carcinoma.

The FDA has approved subdermal implants of the partial opioid agonist buprenorphine (Probuphine – Titan) for maintenance treatment of opioid dependence in patients stabilized on low to moderate doses of transmucosal buprenorphine. Probuphine was designed to provide continuous low levels of buprenorphine for 6 months and to safeguard against illicit use of the drug.

The FDA has approved edaravone (Radicava – Mitsubishi Tanabe Pharma) for treatment of amyotrophic lateral sclerosis (ALS). It is the second drug to be approved in the US for this indication; riluzole (Rilutek, and generics) was approved in 1995. Edaravone was approved for treatment of ALS as Radicut in Japan and South Korea in 2015. It has been used in Japan and other Asian countries since 2001 for treatment of acute ischemic stroke.

The FDA has approved obiltoxaximab (Anthim – Elusys Therapeutics), a toxin-targeting monoclonal antibody, for treatment of inhalational anthrax in combination with antibacterial drugs and prophylaxis of inhalational anthrax when other therapies are unavailable or inappropriate. Raxibacumab, another monoclonal antibody, was approved earlier for the same indication. Like raxibacumab, obiltoxaximab is being manufactured only for the CDC national stockpile and is not available for commercial sale.

The FDA has approved Inbrija (Acorda), an orally inhaled dry-powder formulation of levodopa, for intermittent treatment of "off" episodes in patients with Parkinson's disease (PD) being treated with carbidopa/levodopa (Sinemet, and others).

The investigational oral antiviral drug molnupiravir (Merck/Ridgeback Biotherapeutics) was granted an FDA Emergency Use Authorization (EUA) on December 23, 2021 for treatment of mild to moderate COVID-19 in outpatients ≥18 years old who are at high risk of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative treatment options are not available or clinically appropriate. Paxlovid (Pfizer), nirmatrelvir copackaged with ritonavir, was granted an EUA on December 22, 2021. The IV antiviral drug remdesivir (Veklury) was approved by the...

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.

Epsolay (Galderma), a 5% benzoyl peroxide cream, has been approved by the FDA for treatment of inflammatory lesions of rosacea in adults. It is the first product containing benzoyl peroxide to be approved in the US for treatment of rosacea. Benzoyl peroxide formulations approved for acne have been used off-label to treat rosacea for years, but itching and burning have limited their use.