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Industry News
FDA Reviewing Labeling for Azithromycin, Other Macrolides
FDA on May 17 announced that it is reviewing the results of a federally funded study that found an increased risk of death in patients treated with azithromycin compared with those receiving amoxicillin or ciprofloxacin or people not receiving antimicrobial therapy.
Hospira Recalls Single Hydromophone Lot
Citing overfill concerns, FDA and Hospira announced the recall of a single lot of hydromorphone injection packaged in Hospira's Carpuject syringe system.
GPhA to Launch Drug-Shortage Management Program
A soon-to-launch program developed by the Generic Pharmaceutical Association (GPhA) aims to improve communication between manufacturers, FDA, and other pharmaceutical supply chain stakeholders in an effort to lessen the severity of drug shortages.
Upcoming Changes to Medicare Part D Affect MTM Services
For pharmacists who provide medication therapy management (MTM) services to people with the Medicare Part D prescription drug benefit, the year 2013 means a standardized format for the written summary of annual comprehensive medication reviews and new coverage of barbiturates and benzodiazepines.
Osteoarthritis Guidelines Take Balanced Approach to Therapy
New guidelines from the American College of Rheumatology (ACR) recommend both drug therapy and nonpharmacologic interventions for patients with osteoarthritis of the hand, hip, or knee.
Lenalidomide Ups Risk for New Cancers in Patients With Multiple Myeloma
FDA on May 7 announced safety-related changes to the labeling for lenalidomide.
Taliglucerase Alfa Approved for Gaucher Disease
Pfizer Inc. and Protalix BioTherapeutics Inc. on May 1 announced the approval of taliglucerase alfa for i.v. infusion for the treatment of type 1 Gaucher disease in adults.
New PTCB Chief Seeks to Advance Technician Practice
As pharmacists assume greater patient care roles, opportunities exist for motivated pharmacy technicians to also work at an advanced level—and for stakeholders to drive that process, said Everett McAllister, the new head of the Pharmacy Technician Certification Board (PTCB).
FDA Approves New ED Remedy
FDA on April 27 approved the phosphodiesterase type 5 inhibitor avanafil for the treatment of erectile dysfunction.
OSHA Revises Hazard Communication Standard
The 30-year-old regulation that protects U.S. workers against on-the-job exposure to hazardous chemicals was revamped in March in an attempt to standardize the way chemicals in the workplace are classified and better conform to international hazard communication practices.
Community Pharmacy Accreditation Efforts Advance
This may be the year that efforts to create an accreditation program for community pharmacies come to fruition.
American Regent Recalls Epinephrine Lot 1395
American Regent Inc. today announced it is recalling all ampuls in epinephrine injection lot 1395 because the liquid in some containers is discolored or has small visible particles.
Pipeline Trend Analyst Predicts Top Drug Developments of 2012
Expect FDA to approve a new anticoagulant and perhaps new treatments for multiple sclerosis and obesity before year's end, said Brian Kolling during an April 19 presentation at the Academy of Managed Care Pharmacy meeting in San Francisco.
Aliskiren May Pose Risks for Those With Diabetes, Kidney Impairment
New contraindications and warnings have been added to the labeling for products that contain the renin inhibitor aliskiren, FDA announced today.
Hospira Recalls Morphine Sulfate 4 mg/mL Lot10830LL
Hospira Inc. on April 17 announced it was recalling lot 10830LL of morphine sulfate injection 4 mg/mL because a customer had reported that two of the Carpuject syringes in the lot contained more than 1 mL.
FDA Warns Against Use of Contaminated Ultrasound Gel
Citing an infection risk for patients, FDA today warned health care practitioners to stop using all lots of Other-Sonic Generic Ultrasound Transmission Gel that were produced from June through December of 2011.
FDA Mulls Expanded Universe of Nonprescription Drugs
Some drugs that are now available only with a prescription may one day be obtained after consulting with a pharmacist or answering a series of questions on a computer terminal, under a new system that FDA is considering for nonprescription drug use.
Renewed Focus on Tuberculosis Holds Promise for New Treatments
FDA approved rifampin for the treatment of tuberculosis (TB) in 1971, the same year Intel Corporation invented the first microprocessor.
Some Dietary Supplements Resemble Drugs More Than Food
The addition of drugs and their look-alikes to dietary supplements sold in this country has become a "significant health problem," according to the person who leads FDA’s Division of Dietary Supplement Programs.
Drospirenone-Containing Contraceptives May Up Clot Risk
Women who use oral contraceptives that contain the synthetic progestin drospirenone have a higher risk for blood clots than women whose contraceptive uses a different progestin, FDA announced today in a Drug Safety Communication.

