Articles tagged with "FDA"

Sirukumab Approval Stalls

Michele B. Kaufman, PharmD, BCGP | August 15, 2017

Citing safety concerns, the FDA Arthritis Advisory Committee voted against recommending approval of sirukumab for treating adults with RA…

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

Michele B. Kaufman, PharmD, BCGP | August 13, 2017

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…

Abatacept Approved for Adult PsA

Michele B. Kaufman, PharmD, BCGP | July 31, 2017

The FDA has approved abatacept to treat adults with active psoriatic arthritis. In clinical trials, the treatment has proved effective in both intravenous and subcutaneous forms…

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

Diane Bartz | July 28, 2017

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

Michele B. Kaufman, PharmD, BCGP | July 20, 2017

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 Requests Removal of Opana ER; Plus Abatacept’s New Dosing Option

Michele B. Kaufman, PharmD, BCGP | June 21, 2017

The FDA has asked the manufactures of Opana ER to remove the opioid from the U.S. market due to the public health risk of abuse…

News Updates for Diclofenac Sodium, Denosumab & Sarilumab

Michele B. Kaufman, PharmD, BCGP | June 20, 2017

In drug news, a generic 2% diclofenac sodium solution is now available, denosumab is promising to treat osteoporosis, and the FDA has approved sarilumab to treat adults with RA…

FDA Responds to New Drug Application for Baricitinib

Michele B. Kaufman, PharmD, BCGP | June 15, 2017

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…

FDA Update: Romosozumab’s Uncertain Future; Plus Tocilizumab Approved for GCA

Michele B. Kaufman, PharmD, BCGP | June 9, 2017

Due to possible heart-related side effects, romosozumab is no longer expected to be approved this year for the treatment of osteoporosis…

NSAIDs Increase MI Risk; Plus New Label Warnings for Canagliflozin

Michele B. Kaufman, PharmD, BCGP | May 29, 2017

NSAIDs Increase Myocardial Infarction Risk According a recent meta-analysis of real-world non-steroidal anti-inflammatory drug (NSAID) use, NSAIDs may increase the risk of acute myocardial infarction (AMI). The analysis used individual patient data meta-analysis of studies from healthcare databases in Canada, Finland and the U.K. to determine the time course for risk of AMI, as well…