FDA actions in brief, November 2008 (Gardasil, Gamunex, Alimta, Nasacort AQ, ProAir HFA, Keppra XR, Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System)
Recent FDA approvals (through November 2008) related to Gardasil, Gamunex, Alimta, Nasacort AQ, ProAir HFA, Keppra XR, and Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System
Human papillomavirus (HPV) quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant (Gardasil, Merck) was approved for the prevention of vulvar and vaginal cancers caused by HPV types 16 and 18.
Immune globulin intravenous (human), 10% caprylate/chromatography purified (Gamunex, Talecris) was approved for the treatment of chronic inflammatory demyelinating polyneuropathy.
A drug-eluting stent (Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System, Boston Scientific) was approved for use in small coronary vessels for the treatment of coronary artery disease.
Triamcinolone acetonide (Nasacort AQ Nasal Spray, Sanofi-Aventis) was approved for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients aged 2 to 5 years.
Albuterol inhalation aerosol (ProAir HFA, Teva) was approved for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients aged 4 to 11 years.
Levetiracetam extended-release tablets (Keppra XR, UCB) were approved as an adjunctive therapy for the treatment of partial-onset seizures in epileptic patients aged ≥16 years.
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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