The FDA has approved a 1% cream formulation of the antiparasitic drug ivermectin (Soolantra – Galderma) for topical treatment of inflammatory lesions of rosacea. Ivermectin is available in the US in tablets (Stromectol, and generics) for treatment of onchocerciasis and other worm infestations and as a 0.5% lotion (Sklice) for treatment of head lice.

The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have been approved by the FDA for use together for a sixth indication: treatment of low-grade glioma (LGG) with a BRAF V600E mutation in patients ≥1 years old who require systemic therapy. This combination is the first systemic therapy to be approved in the US for first-line treatment of LGG with a BRAF V600E mutation in pediatric patients. The FDA also approved new oral formulations of both drugs for patients who are unable to swallow dabrafenib capsules or trametinib...

The FDA has issued new warnings about the use of the opioid analgesics codeine and tramadol in children, particularly those <12 years old, and in breastfeeding women due to concerns about the risk of respiratory depression and death. The FDA previously issued warnings about these drugs in 2013 and 2015.

Mycophenolate mofetil (CellCept - Roche) has been approved by the US Food and Drug Administration for oral use in preventing organ rejection in patients receiving allogeneic renal transplants. It is being promoted as an improvement over azathioprine (Imuran) for concurrent use with cyclosporine (Sandimmune; Neoral) and corticosteroids.

Bromfenac sodium (Duract - Wyeth-Ayerst), a nonsteroidal anti-inflammatory drug (NSAID), has been approved by the US Food and Drug Administration (FDA) and is being heavily advertised as an alternative to narcotics for short-term treatment of pain.

Rifapentine, a long-acting analog of rifampin developed in the 1960's, has received an accelerated approval from the FDA for oral use, with at least one other drug, in the treatment of pulmonary tuberculosis.

The FDA has approved a rectal foam formulation of the corticosteroid budesonide (Uceris - Salix/Valeant) for induction of remission in patients with active mild to moderate distal ulcerative colitis (UC) extending up to 40 cm from the anal verge. Budesonide is also available as oral extended-release tablets (also branded as Uceris) for use in patients with UC and as oral enteric-coated tablets (Entocort EC, and generics) for treatment of Crohn's disease.

The oral kinase inhibitor alpelisib (Vijoice – Novartis) has been approved by the FDA for treatment of patients ≥2 years old with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic treatment. Alpelisib is the first drug to be approved in the US for this indication. It was also approved in 2019 as Piqray for use in combination with fulvestrant for treatment of certain types of breast cancer.

Sitagliptin (Januvia) and metformin (Glucophage, and others) are now available in a single tablet (Janumet - Merck) for treatment of type 2 diabetes. The combination is approved by the FDA for use in patients not adequately controlled by sitagliptin or meformin alone or in those already taking both drugs. Metformin is also available in combination with the thiazolidinediones pioglitazone and rosiglitazone and with the sulfonylureas glipizide and glyburide.

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.