Articles tagged with "FDA"

FDA Approves Updated Labeling on Risk of Osteonecrosis of the Jaw for Denosumab

Michele B. Kaufman, PharmD, BCGP | August 24, 2016

Denosumab’s labeling now says a patient’s risk of developing osteonecrosis of the jaw may increase with prolonged exposure…

FDA Update: Committees Recommend Approvals for Abuse-Deterrent Opioid & Brodalumab

Michele B. Kaufman, PharmD, BCGP | August 17, 2016

FDA advisory committees recommend the approvals of the abuse-deterrent opioid morphine sulfate for pain and brodalumab for plaque psoriasis…

Rheumatology Drug Updates: Infliximab Biosimilar Cross Reacts to Infliximab Antibodies

Michele B. Kaufman, PharmD, BCGP | August 11, 2016

Cross Reactions A recent study published online in March in the Annals of the Rheumatic Diseases investigated if the infliximab biosimilar (CT-P13, infliximab-dyyb), which is marketed in Europe as Inflectra and Remsima, can be safely and effectively substituted for infliximab (Remicade).1 Infliximab and its biosimilar are manufactured via the same process. Researchers set out to…

U.S. Panel Backs Approval of Abuse-Resistant Opioid Painkiller

Reuters Staff | August 7, 2016

WASHINGTON (Reuters)—A U.S. advisory panel on Thursday recommended approval of Egalet Corp’s long-acting opioid painkiller, Arymo ER (morphine sulfate), saying it dulls pain and could deter abuse by addicts seeking a quick high. The panel recommended that the U.S. Food and Drug Administration (FDA) approve the drug and said it deters, but does not eliminate,…

New FDA Warnings: Patients on SGLT2 Inhibitors at Risk of Acute Kidney Injury & Loperamide Abuse on the Rise

Michele B. Kaufman, PharmD, BCGP | July 27, 2016

The FDA is strengthening its warning that canagliflozin and dapagliflozin may increase the risk for acute kidney injury in some patients. Also, the FDA has issued a warning that patients should not exceed recommended doses of loperamide due to increased risks of serious cardiac events…

U.S. FDA Panel Backs Valeant Psoriasis Drug with Risk Program

Toni Clarke | July 21, 2016

(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide, an advisory committee to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committees but typically…

Tildrakizumab Promising for Plaque Psoriasis; FDA Approves Adalimumab to Treat Panuveitis

Michele B. Kaufman, PharmD, BCGP | July 20, 2016

n clinical trials, tildrakizumab was more effective than etanercept and placebo at treating moderate to severe plaque psoriasis. Adalimumab has received approval for treating non-infectious intermediate, posterior and panuveitis—its 10th FDA indication…

Biosimilars Update: FDA Panel Voted to Approve Biosimilars for Etanercept & Adalimumab at July Meeting

Michele B. Kaufman, PharmD, BCGP | July 15, 2016

In July, the FDA’s Arthritis Advisory Committee will meet and review proposed biosimilars for etanercept and adalimumab to treat multiple rheumatic diseases…

FDA Panel Supports Novartis Biosimilar of Etanercept

Reuters Staff | July 14, 2016

(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…

FDA Panel Backs Amgen Biosimilar of Humira

Toni Clarke | July 13, 2016

(Reuters)—Amgen Inc.’s cheaper version of AbbVie’s top-selling arthritis drug adalimumab (Humira) is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26–0 that the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis, was similar in…