SILVER SPRING, Md. — Citing dangers from combined use, the Food and Drug Administration is requiring classwide changes to labeling for opioid analgesics, prescription opioid cough products and benzodiazepines, a group of central nervous system depressant drugs. The FDA said Wednesday that the changes mandate boxed warnings — the agency’s strongest warning — and patient
DEERFIELD, Ill. — Walgreens plans to participate in the U.S. Precision Medicine Initiative Cohort Program, part of a sweeping federal medical research initiative to help develop individualized care based on a person’s genomic makeup. Walgreens said it’s taking part in the PMI Cohort Program via an initial $20 million grant awarded to The Scripps Research
FORT WORTH, Texas — Galderma Laboratories L.P. has gained Food and Drug Administration approval for Differin Gel, an over-the-counter treatment for acne. Galderma said Friday that Differin Gel (adapalene gel 0.1%) is the first and only OTC acne product with a full prescription-strength retinoid, and the product represents the first new, FDA-approved active ingredient to
WASHINGTON — The Food and Drug Administration is again postponing the release of a final rule that would change generic drug labeling requirements. In a Federal Register notice this week, the FDA indicated that it aims to implement the final rule in April 2017, though many industry stakeholders had expected the agency to do so
WASHINGTON — Amid calls for a quicker approval process, the Food and Drug Administration last year cleared for market the most generic drug products in its history. The FDA said it approved or issued tentative approvals for more than 700 generic drugs in 2015. The announcement may help to blunt criticism from some federal legislators
WASHINGTON — Just over a year after approving its first biosimilar product, the Food and Drug Administration has approved its second, Celltrion’s Inflectra (biosimilar infliximab). Inflectra is a biosimilar to Janssen Biotech’s Remicade (infliximab), originally licensed in 1998. Inflectra is indicated for reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque
WASHINGTON — The U.S. Senate overwhelmingly confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration. Califf, who was deputy commissioner for medical products and tobacco, was nominated as FDA commissioner by President Barack Obama in mid-September. No significant opposition was expected for his confirmation hearing on Tuesday, as the Senate voted 89-4
ALEXANDRIA, Va. — In comments to Congress, the National Community Pharmacists Association called for more oversight of pharmacy benefit management (PBM) companies. NCPA said payers, pharmacy patients and pharmacists could see “tangible benefits” from increased transparency into PBM business practices and potential conflicts of interests. The association submitted its comments to the House Committee on
WASHINGTON — The Food and Drug Administration has established the Office of Dietary Supplement Programs (ODSP), raising the program from its previous status as a division under the Office of Nutrition Labeling and Dietary Supplements. The FDA said Monday that it’s also in the process of identifying permanent leadership for ODSP. Meanwhile, Bob Durkin will
WASHINGTON — The staff of the Federal Trade Commission has submitted comment for the Food and Drug Administration’s draft guidance on nonproprietary names for biological products. The FTC said Wednesday that its staff comment expressed concern that the FDA draft guidance on biosimilar naming may hinder competition and, as a result, recommended that the agency
WASHINGTON — The Food and Drug Administration’s current deputy commissioner for medical products and tobacco is likely to become the organization’s next commissioner. Dr. Robert Califf, a cardiologist and clinical researcher long affiliated with Duke University, was nominated by President Obama earlier this month to head up the FDA. Though Califf must face Senate confirmation
WASHINGTON — The Food and Drug Administration’s current deputy commissioner for medical products and tobacco is likely to become the organization’s next commissioner. Dr. Robert Califf, a cardiologist and clinical researcher long affiliated with Duke University, on Tuesday was nominated as FDA commissioner by President Barack Obama. On Wednesday, his nomination was sent to the
WASHINGTON — Early feedback on the Food and Drug Administration’s proposal on naming conventions for biosimilars shows a mixed response. Late late week, the FDA published draft guidance recommending that reference biologic products and biosimilars have nonproprietary names that share a core drug substance name and an FDA-designated suffix unique for each product. For interchangeable
RALEIGH, N.C. — Sprout Pharmaceuticals Inc. has gained Food and Drug Administration clearance to market Addyi, which the company calls the first FDA-approved medication for hypoactive sexual desire disorder (HSDD) in women. Sprout said late Tuesday that Addyi (flibanserin, 100 mg) is slated to be released by Oct. 17. “It has been a remarkable journey to
