Tag: fda
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FDA approves Amgen’s copy of AbbVie arthritis drug Humira
The U.S. Food and Drug Administration on Friday approved Amgen Inc’s biosimilar version of AbbVie’s top-selling arthritis drug, Humira. The drug, Amjevita, known also as adalimumab-atto, was approved to treat rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, psoriasis and other conditions. Amjevita is the fourth biosimilar to be approved by the FDA and is expected to…
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FDA halts sale of some antibacterial hand, body wash products
The move affects 2,100 products, or roughly 40 percent of the over-the-counter antibacterial soap market, Dr. Theresa Michele, director of the FDA’s division of nonprescription drug products, told reporters on a conference call. The ruling does not affect alcohol-based hand sanitizers or antibacterial products used in hospitals and clinics. The agency said it is banning…