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Alpidem (Ananxyl) 1995. Worldwide. Not approved in the US, withdrawn in France in 1994 [4] and the rest of the market in 1995 because of rare but serious hepatotoxicity. [3] [5] Alosetron (Lotronex) 2000. US. Serious gastrointestinal adverse events; ischemic colitis; severe constipation. [2]
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests ...
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From Wikipedia, the free encyclopedia. Type of warning that appears on the package insert for certain prescription drugs. An exemplary black box warning, as seen in context, in FDA's Challenges and Issues with Safety-Related Information in the Prescribing Information slide desk. For emphasis, the text is bolded and surrounded by a black outline ...
Doxorubicin, sold under the brand name Adriamycin among others, is a chemotherapy medication used to treat cancer. [ 10] This includes breast cancer, bladder cancer, Kaposi's sarcoma, lymphoma, and acute lymphocytic leukemia. [ 10] It is often used together with other chemotherapy agents. [ 10]
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