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.
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.
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
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