A new fixed-dose tablet (PrandiMet - Novo Nordisk) combining metformin (Glucophage, and others) and repaglinide (Prandin) has been approved by the FDA for treatment of type 2 diabetes in patients already taking both metformin and repaglinide, or for patients not adequately controlled on either drug alone.

The FDA has approved a new Japanese encephalitis vaccine (Ixiaro - Intercell/Novartis). It will replace JEVax (Sanofi Pasteur), which has had tolerability and safety problems and is no longer being manufactured.

The FDA has approved ocrelizumab (Ocrevus – Genentech), a humanized anti-CD20 monoclonal antibody, for treatment of adults with primary progressive or relapsing multiple sclerosis (MS). It is the first anti-CD20 monoclonal antibody to be approved for treatment of MS and the first disease-modifying drug to be approved in the US for primary progressive MS.

The FDA has approved erenumab-aooe (Aimovig – Amgen/Novartis), a once-monthly, subcutaneously-injected, monoclonal antibody against the calcitonin gene-related peptide receptor, for preventive treatment of migraine in adults. It is the first drug in its class to be approved by the FDA.

The FDA has approved Trelegy Ellipta (GSK), a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate, the long-acting antimuscarinic agent (LAMA) umeclidinium, and the long-acting beta₂-agonist (LABA) vilanterol. It is available as a dry powder inhaler for once-daily maintenance treatment of COPD and to reduce COPD exacerbations in patients with a history of exacerbations. Trelegy Ellipta is the first three-drug inhaler for treatment of COPD to become available in the US.

The FDA has approved ozanimod (Zeposia – Celgene), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). It is the third oral S1P receptor modulator to be approved in the US for treatment of relapsing forms of MS; siponimod (Mayzent) is also indicated for use in adults, and fingolimod (Gilenya) is approved for use in patients ≥10 years old.

The FDA has approved Winlevi (Sun), a 1% cream formulation of the androgen receptor inhibitor clascoterone, for treatment of acne vulgaris in patients ≥12 years old. It is the first topical androgen receptor inhibitor to be approved by the FDA.

The FDA has approved Symbravo (Axsome), an oral fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam and the 5-HT_1B/1D receptor agonist (triptan) rizatriptan (Maxalt, and generics), for acute treatment of migraine with or without aura in adults. It is the second combination of an NSAID and a triptan to be approved for migraine treatment. An oral fixed-dose combination of sumatriptan and naproxen (Treximet, and generics) is approved for use in patients ≥12 years old.

Excessive exposure to ultraviolet (UV) radiation can cause erythema, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and safety. In 2021, the FDA proposed a rule that would require additional safety studies for some sunscreen active ingredients and mandate better UVA protection in sunscreen products.

Ramelteon (Rozerem - Takeda), a melatonin receptor agonist, has been approved by the FDA for treatment of insomnia characterized by difficulty falling asleep. Unlike all other prescription hypnotics, which are classified as schedule IV drugs, ramelteon is not a controlled substance.