Articles tagged with "FDA"

Ustekinumab Approved for Use in Adolescents with Plaque Psoriasis

Michele B. Kaufman, PharmD, BCGP | November 3, 2017

In October, the FDA approved ustekinumab to treat patients 12 years or older who have moderate to severe plaque psoriasis…

FDA Sets Stricter Requirements for Immediate-Release Opioids to Prevent Misuse & Abuse

Michele B. Kaufman, PharmD, BCGP | October 27, 2017

The FDA is expanding its Risk Evaluation and Mitigation Strategy (REMS) to include manufacturers of immediate-release opioids. The makers of these drugs will soon be required to provide training and education to healthcare professionals on the proper prescription and use of the drugs for pain management…

Supplemental Application for Denosumab Goes to FDA

Michele B. Kaufman, PharmD, BCGP | October 25, 2017

The FDA accepted for review a supplemental biologics license application for denosumab to treat patients with glucocorticoid-induced osteoporosis…

FDA Teams with Medical Companies in Puerto Rico to Tackle Shortages

Reuters Staff | October 22, 2017

(Reuters)—The head of the U.S. Food and Drug Administration said the agency was working with several pharmaceutical and medical device companies in Puerto Rico to prevent shortages of medical products in the U.S. as it joins a massive effort to help rebuild the island that was ravaged by Hurricane Maria.1 Drugmakers are working to get…

Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab

Mary Beth Nierengarten | October 17, 2017

FDA Approves Adalimumab-adbm On Aug. 29, the FDA approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab).1 Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis and ankylosing spondylitis, and moderate to severe plaque psoriasis. The treatment has also been approved for moderate…

Flexion’s Knee Pain Drug Gets FDA Approval

Divya Grover | October 9, 2017

(Reuters)—Flexion Therapeutics Inc. said its injectable drug to treat osteoarthritis-related knee pain was approved by the U.S. Food and Drug Administration. The approval comes at a time when U.S. federal authorities are implementing a slew of measures to combat opioid abuse, with President Donald Trump in August declaring the opioid epidemic a national emergency. The…

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…