Amerifit launches trio of brand Web sites
CROMWELL, Conn. Amerifit Brands on Monday announced the Web site launches of three of its top consumer health brands: Estroven.com, Culturelle.com and AzoProducts.com.
“We have made significant improvements to the websites of three Amerifit Brands companies with new features and capabilities that we believe will serve as valuable resources to consumers looking to maintain and improve their health,” stated Cyrill Siewert, chief executive officer of Amerifit Brands.
Estroven.com offers perimenopausal and menopausal women (ages 40–60) an updated platform where they can find women’s health and menopause-related information. Women are encouraged to visit the website’s unique Lifestyle Lounge, where they can read and share stories and jokes about menopause.
SCOLR to begin testing 12-hour time-release ibuprofen
BELLEVUE, Wash. SCOLR Pharma on Thursday announced the initiation of the first of three trials to evaluate the safety and efficacy of its over-the-counter 12-hour extended-release ibuprofen. The company expects to complete the trials by the end of the first quarter of 2008, and plans to file a New Drug Application with the Food and Drug Administration in the second half of 2008.
If its ibuprofen product is approved, SCOLR believes its product would be the first and only 12-hour, extended-release ibuprofen product on the market.
“These Phase III trials are a key milestone for SCOLR,” stated Daniel Wilds, SCOLR Pharma’s president and chief executive officer. “They represent an important step toward achieving our goal of providing an OTC 12-hour CDT-based formulation of ibuprofen. We believe the substantial in vivo data accumulated from previous trials, together with our development and successful scale-up activities, demonstrate commercial viability for our product, and we look forward to successful completion of these studies and eventual approval by the FDA.”
FDA seizes over $300,000 of product from General Theraputics
ROCKVILLE, Md. The Food and Drug Administration on Wednesday directed the seizure of more than $300,000 worth of product, including NC Solution, an antifungal product, and other drugs for human or animal use, dietary supplements and the ingredients to make those products because some lacked FDA approval and all were maintained under what the FDA defined as “grossly unsanitary conditions” by General Therapeutics of St. Louis, Mo.
“The action taken Wednesday is the culmination of the concerted efforts by the FDA to get the firm to follow the law when it comes to manufacturing safe products for consumers,” stated Margaret Glavin, FDA associate commissioner for regulatory affairs.
The FDA considers NC Solution to be a drug because it is intended for the use in the diagnosis, cure, or treatment of disease in people or animals. NC Solution is also a new drug because it is not generally recognized as safe and effective for its intended uses.
In August and September, FDA inspectors found that the company was still manufacturing drugs and dietary supplements under unsanitary conditions, including insects and rodent filth on and around manufacturing equipment, despite a warning by FDA of serious violations in 1999. Following the 1999 inspection, a company official told the FDA in January, 2000, it would stop manufacturing drugs.
The FDA recommends that consumers who have any products manufactured by General Therapeutics, including NC Solution, consult their health care providers about discontinuing use and if they have experienced any adverse events that they suspect are related to the product’s use.
Catherine Hanaway, U.S. attorney for the Eastern District of Missouri, filed the complaint requesting the seizure, and her office will continue to coordinate with the FDA to ensure proper disposal of the seized items.