Articles tagged with "FDA"

Efficacy Studied Following Accelerated Drug Approvals

Michele B. Kaufman, PharmD, BCGP | October 2, 2017

In recent years, the number of drugs to receive accelerated FDA approval has increased. A new study examined whether these drugs have demonstrated efficacy in post-approval trials…

FDA Approves Lesinurad + Allopurinol

Michele B. Kaufman, PharmD, BCGP | September 19, 2017

Duzallo, a combination of lesinurad and allopurinol, was approved by the FDA in August to treat hyperuricemia associated with gout…

Abatacept Approved for Psoriatic Arthritis in Adults; Sirukumab Approval Stalls

Michele B. Kaufman, PharmD, BCGP | September 17, 2017

Abatacept Approved for Adult PsA On June 30, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia) to treat adults with active psoriatic arthritis (PsA).1 Abatacept is available as both an intravenous formulation and a subcutaneous injection.2 The approval was based on results of two randomized, double-blind, placebo-controlled trials, PsA-I and PsA-II, during which…

FDA Update: Biosiomilar to Adalimumab Receives FDA Approval

Michele B. Kaufman, PharmD, BCGP | September 6, 2017

The FDA has approved adalimumab-adbm, a biosimilar, to treat multiple chronic inflammatory diseases…

FDA Committee Recommends Tofacitinib Approval

Michele B. Kaufman, PharmD, BCGP | August 22, 2017

The FDA Arthritis Advisory Committee voted 10 to 1 to recommend approval of tofacitinib to treat psoriatic arthritis…

Flimsy Evidence Behind Many FDA Approvals

Will Boggs, MD | August 21, 2017

(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 | August 21, 2017

(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…

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…