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Articles tagged with "FDA"

Flimsy Evidence Behind Many FDA Approvals

Will Boggs, MD  |  

(Reuters Health)—Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in JAMA, online Aug. 15. The Accelerated Approval pathway makes potentially promising investigational medicines available for use before the…

FDA Approves Duzallo for Hyperuricemia in Patients with Uncontrolled Gout

Reuters Staff  |  

(Reuters)—Ironwood Pharmaceuticals Inc. said on Monday the U.S. Food and Drug Administration (FDA) approved its oral drug to treat a condition associated with gout. The company’s once-daily drug, Duzallo (lesinurad and allopurinol), was approved to treat hyperuricemia in patients with gout, Ironwood said. Duzallo combines the standard-of-care treatment, allopurinol, with Ironwood’s lesinurad to treat inefficient…

Rheumatology Drug Updates: Opana ER Painkiller Pulled from U.S. Market; Upadacitinib to Treat RA, and More

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Opana ER Pulled from U.S. Market Last month, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to remove oxymorphone hydrochloride extended release (Opana ER) from the U.S. market due to public health consequences related to abuse. The agency has concerns that the risks presented by the treatment do not outweigh its benefits.1 On…

U.S. House Panel Spotlights Use of FDA Rules to Slow Generic Drugs

Diane Bartz  |  

WASHINGTON (Reuters)—Republican and Democratic lawmakers on Thursday discussed ways to prevent drugmakers from using rules developed to safeguard patients to instead block the sale of cheaper medicines. The focus at a hearing, held by members of the House Judiciary Committee’s antitrust subcommittee, was on the use by some brand name drug companies of a U.S….

Rheumatology Drug Updates: Uncertain Future for Romosozumab, Plus FDA Approves Tocilizumab for GCA

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Romosozumab’s Future Is Uncertain Romosozumab, which has the possible U.S. brand name Evenity, is awaiting approval from the FDA.1 The treatment is an investigational, injectable biologic for treating osteoporosis. It increases bone formation and bone density, reducing a patient’s risk of fractures. The manufacturer no longer expects the FDA to approve the drug this year…

FDA Responds to New Drug Application for Baricitinib

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Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…