The FDA today posted warning letters issued to 2 companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims.
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FDA OKs First Treatment for Pediatric, Adult Patients with Rare Immune Disease
November 20th 2018Officials with the FDA have approved emapalumab (Gamifant) for the treatment of pediatric and adult patients with primary hemophagocytic lymphohistiocytosis (HLH), making it the first FDA-approved drug specifically indicated for this disease.
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FDA OKs Eltrombopag Indication for Adult, Pediatric Severe Aplastic Anemia
November 19th 2018The FDA expanded the label for eltrombopag (Promacta) to now include indication for adults and pediatric patients 2 years and older with severe aplastic anemia in combination with standard immunosuppressive therapy.
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FDA Approves New Combination HIV Drug
November 18th 2018The FDA has approved lamivudine and tenofovir disoproxil fumarate (Temixys, Celltrion) tablets, 300 mg/300 mg in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.
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Eltrombopag Granted FDA Approval for Severe Aplastic Anemia
November 18th 2018he FDA has expanded the approval of eltrombopag (Promacta) in combination with standard immunosuppressive therapy (IST) to include newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia.
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FDA OKs Rifamycin for Travelers' Diarrhea Caused by Noninvasive E coli
November 17th 2018Rifamycin's effectiveness was shown in a randomized, placebo-controlled clinical trial during which the drug significantly reduced symptoms of travelers’ diarrhea in adults afflicted with the condition in Guatemala and Mexico.
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