FDA Approvals Monthly Roundup: June 2020

FDA Approvals Monthly Roundup: June 2020

The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs. Each month, the administration approves numerous new therapeutics. We have summarized the FDA approvals for June below. You can use the hot links to learn more about the drugs.

Artesunate (DB09274), an artemisinin derivative indicated for the initial treatment of severe malaria.

Fluoroestradiol F-18 (DB15690), a radio-imaging agent for the detection of estrogen receptor-positive breast cancer.

Flortaucipir F-18 (DB14914), a radioactive molecule for the PET imaging of aggregated tau proteins in Alzheimer's disease.

Inebilizumab (DB12530), a monoclonal anti-CD19 antibody for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

Lurbinectedin (DB12674), a DNA alkylating agent for the treatment of metastatic small-cell lung cancer (SCLC).

Remimazolam (DB12404), an ultra short-acting benzodiazepine for sedation during short procedures.

Fenfluramine (DB00574), a serotonergic phenethylamine for the treatment of seizures associated with Dravet syndrome.

Mycapssa (DB00104), the first oral delayed-release somatostatin analog for the treatment of acromegaly.

Triheptanoin (DB11677), a medium-chain triglyceride as a source of calories and fatty acids in the treatment of long-chain fatty acid oxidation disorders