Scientific Labs agrees to halt production of cough-cold medicines
ROCKVILLE, Md. The Food and Drug Administration last week announced that Scientific Laboratories, and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.
Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products. The government’s complaint, filed by the U.S. Department of Justice, alleged that the company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements.
“The FDA will not allow a company to put the public’s health at risk,” stated Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”
The unapproved new drugs manufactured and marketed by Scientific Labs as prescription cough and cold products included: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.
The decree was signed May 8 by Judge William Quarles, Jr., in the U.S. District Court for the District of Maryland.
New Winn Dixie software credits eligible purchases to FSA, HSA
JACKSONVILLE, Fla. Winn-Dixie May 16 announced the grocery chain would employ upgraded software will make it easier for customers to credit appropriate over-the-counter and prescription medicines to their flexible-spending or health-savings accounts by identifying eligible products, charging them directly to the person’s FSA or HSA account, and then automatically subtracting that amount from the total owed for all other purchases
Formerly, customers using HSA/FSA cards to purchase these items had to pay for them at the pharmacy and then go to the regular checkout lanes to pay for the remainder of their items.
“This is all about making the shopping experience better for our customers,” stated Robin Miller, Winn-Dixie’s director of communications. “This service enhancement also provides a separate listing and total cost of qualifying purchases on the register receipt, which is helpful for many customers. We are very pleased to be able to offer this added convenience, especially in these challenging economic times.”
Unilever touts efficacy of new appetite-suppressing milkshake
GENEVA Unilever has developed a new appetite suppressant that traps the gas from food to create the feeling of satiety, the company announced Wednesday.
Research showed the suppressant, which comes in the form of a milkshake-like drink, is more effective than Unilever’s Slim-Fast drinks.
Researchers tested the drink on 24 subjects at breakfast, giving one group the new drink and the other group the regular Slim-Fast drink. Subjects given the new drink responded that they felt fuller at different intervals over the four-hour test.