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FDA is requiring that manufacturers of tumor necrosis factor blockers perform enhanced safety surveillance in children, teenagers, and young adults, the agency said on November 3 in an ongoing safety review of this class of biologic products.

Liquid acetaminophen for infants is being shipped to hospitals and drug stores in new concentrations, even though manufacturers may not be providing notice about the concentration change, according to the Institute for Safe Medication Practices.

The Centers for Disease Control and Prevention recently launched a new antibiotic tracking system, allowing hospitals to monitor their antibiotic use electronically.

Pharmacy association veteran Kathleen Jaeger will publicly advance the role of pharmacists in patient care in a newly created position with the National Association of Chain Drug Stores.

Pharmacy and medical groups are suing the California Department of Health Care Services and the U.S. Department of Health and Human Services over the Centers for Medicare and Medicaid Services’ recent approval of a 10% reimbursement rate cut in California’s Medicaid program.

FDA has approved aflibercept (Eylea Injection, Regeneron), known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) age-related macular degeneration in patients aged 60 and older at a recommended dose of 2 mg every 4 weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months).

FDA Commissioner Margaret A. Hamburg, MD, announced the agency's decision to revoke the breast cancer indication for bevacizumab (Avastin), noting that the benefits do not outweigh the potentially life-threatening side effects, such as heart attack or heart failure, high blood pressure, bleeding and hemorrhaging, and the development of perforations in different parts of the body, such as the nose, stomach, and intestines.

The NACDS lauded the U.S. Senate’s vote last week to defeat an amendment that would have allowed “personal importation” of prescription medications from Canada.

FDA has approved bupivacaine hydrochloride injection, USP (Sagent and Strides Arcolab), a local or regional anesthetic, for use in surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures.

OTC Product News

In this section we showcase products and product news that ran up against space limitations or fell outside the parameters of recently featured categories in the print edition.