FDA actions in brief

An estradiol transdermal gel (Elestrin [formerly Bio-E-Gel], Bradley/BioSante) was approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.

FDA approved calcium hydroxylapatite (Radiesse, BioForm Medical) for the long-lasting correction of moderate-to-severe facial wrinkles and folds and for the long-lasting correction of facial lipoatrophy in patients with HIV.

A kit containing hydroxocobalamin, intravenous tubing, and a sterile spike for reconstituting the drug product with saline (Cyanokit, EMD/Dey) was approved for the treatment of known or suspected cyanide poisoning.

A new refrigerated formulation of influenza virus vaccine live, intranasal (FluMist, MedImmune) was approved for the active immunization for the prevention of disease caused by influenza A and B viruses in healthy children, adolescents, and adults.

FDA approved formoterol inhalation powder (Foradil Certihaler, Novartis/SkyePharma) for the treatment of asthma and the prevention of bronchospasm in adults and children aged ≥5 years with reversible obstructive airway disease.