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Medication Approvals

Information about U.S. Food and Drug Administration medication approvals.

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by Ryan Chandanais, M.S., emerging therapeutics analyst, Diplomat Specialty Pharmacy In 2015, the specialty drug pipeline is expected to continue to produce valuable new treatments for patients across a variety of disease states. The oncology and rare disease pipelines remain particularly strong, with several approvals expected in each area. Chronic hepatitis C (CHC) still has a few promising dru...

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by Paul Brumley, Pharm.D., PGY1 pharmacy resident, St. Joseph Mercy Ann Arbor  According to the Infectious Diseases Society of America (IDSA), antimicrobial resistance has become an imminent threat in the health care world, and the tangible evidence of this is becoming more apparent every year. Antibiotic-resistant pathogens lead to devastating consequences, including nearly 99,000 deaths ...

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On March 6, 2015, the U.S. Food and Drug Administration (FDA) announced the approval of Zarxio® (filgrastim-sndz) as a biosimilar to Neupogen®. The formulation of Zarxio differs from that of U.S.-licensed Neupogen in one inactive component, and a review of evidence demonstrated that “there are no clinically meaningful differences between Zarxio and U.S.-licensed Neupogen,” acco...

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On Wednesday, Jan. 7, 2015, a U.S. Food and Drug Administration (FDA) Advisory Panel recommended approval of the first U.S. biosimilar medication Zarxio, which is Sandoz’s (a unit of Novartis) equivalent to Neupogen currently manufactured by Amgen. According to the advisory panel, Zarxio should be approved for the same five conditions Neupogen is approved to treat. The FDA will most likely m...

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The U.S. Food and Drug Administration (FDA) recently approved three new medications. Read more below and click on the links provided to access the full FDA press release for each medication online. The agency approved BioCryst Pharmaceuticals’ Rapivab (peramivir), the first neuraminidase inhibitor approved for intravenous administration to treat influenza in adults. The treatment, mad...

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