Articles tagged with "Food and Drug Administration"

FDA Issues Boxed Warning for Febuxostat & Approves Colchicine for Gout Flare

Michele B. Kaufman, PharmD, BCGP | March 12, 2019

The FDA has issued a boxed warning for febuxostat after a safety study found an increased risk of heart-related and other death in RA patients…

Safety Risk with Higher Dose Tofacitnib

Michele B. Kaufman, PharmD, BCGP | March 6, 2019

According to the FDA, an ongoing safety trial found higher dose tofacitinib increased the risks of pulmonary embolism and death in RA patients…

U.S. FDA Chief Gottlieb Resigns

Yasmeen Abutaleb | March 5, 2019

WASHINGTON (Reuters)—U.S. Food and Drug Administration (FDA) Chief Scott Gottlieb said he plans to step down in a month, calling into question how the agency will handle critical issues, such as e-cigarette use among teens and efforts to increase competition in prescription drugs. The U.S. Department of Health and Human Services (HHS), which oversees the…

FDA Update: Committee Recommends 2 mg Baricitinib Approval; HLH Identified as Serious Adverse Event for Lamotrigine

Michele B. Kaufman, PharmD, BCGP | May 8, 2018

The FDA Arthritis Advisory Committee has recommended the approval of 2 mg baricitinib (but not in a 4 mg dose) for treating adults with moderate to severe active RA…

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…

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…

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…

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…