FDA Actions in Brief August 2012
September 1st 2012Recent FDA Approvals (through August 2012) related to (CSL Limited, GlaxoSmithKline Biologicals, ID Biomedical Corp, MedImmune Vaccines, Novartis Vaccines and Diagnostics Limited, Sanofi Pasteur, Genentech, Talon Therapeutics, Amarin, Regeneron Pharmaceuticals, Horizon Pharma, Forest Pharmaceuticals, Onyx Pharmaceuticals, Novartis, Pfizer, Sagent Pharmaceuticals)
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Belviq (Lorcaserin): A 5-HT2C receptor agonist indicated to treat certain overweight or obese adults
September 1st 2012New molecular entity: FDA approved Lorcaserin (Belviq, Arena Pharmaceuticals GMBH), as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index deemed obese and the presence of at least 1 weight-related comorbid condition.
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Teduglutide: A novel recombinant analog of human glucagon-like peptide-2 for short bowel syndrome
September 1st 2012Teduglutide is a recombinant analog of human glucagon-like peptide-2 that is awaiting FDA approval for the treatment of short bowel syndrome (SBS) as a once-daily subcutaneous injection.
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FDA approves new treatment for a type of late-stage prostate cancer
August 31st 2012FDA approved enzalutamide (Xtandi, Astellas Pharma U.S. Inc. and Medivation) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.
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FDA recommends against use of Revatio in children with pulmonary hypertension
August 31st 2012FDA issued a Drug Safety Communication on sildenafil (Revatio, Pfizer), following the observation in a long-term extension of a clinical trial in pediatric patients with pulmonary arterial hypertension of an increase in mortality with increasing Revatio dose.
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FDA approves new treatment for severe neutropenia in certain cancer patients
August 30th 2012FDA has approved tbo-filgrastim (Sicor Biotech UAB, a member of Teva Corporation), or XM02 filgrastim, the first new granulocyte colony-stimulating factor to be approved in the United States in more than 10 years to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia.
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FDA approves first drug formulated for children with rare brain tumor
August 29th 2012FDA has approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis), a new pediatric dosage form of the anti-cancer drug everolimus (Afinitor, Novartis) used to treat a rare brain tumor called subependymal giant cell astrocytoma.
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FDA approves new combination tablet for HIV treatment in some patients
August 29th 2012FDA has approved elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Stribild, Gilead Sciences), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.
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FDA approves tapentadol ER for neuropathic pain associated with DPN
August 29th 2012FDA has approved the supplemental New Drug Application for tapentadol extended-release tablets (Nucynta ER, Janssen), an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
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