FDA: Tri-Med selling unapproved, adulterated drugs
SILVER SPRING, Md. U.S. Marshals earlier this month seized articles of prescription and over-the-counter drug products from Tri-Med Labs in Somerset, N.J., at the request of the Food and Drug Administration, the agency announced Wednesday. The seizure warrant, issued by the U.S. District Court for the District of New Jersey and unsealed this week, shows the drugs are unapproved and adulterated new drugs.
“The FDA is taking this action because Tri-Med has refused to take these unapproved products off the market after it received warning letters and regulatory meetings,” stated Dara Corrigan, the FDA’s associate commissioner for regulatory affairs. “This action shows the FDA’s commitment to protecting the public health from the dangers of unapproved or adulterated drug products.”
The FDA has been on the case approaching 13 years — FDA inspections of Tri-Med since 1997 revealed Tri-Med continued to manufacture and distribute unapproved, misbranded and adulterated drugs with significant Good Manufacturing Practices violations.
Matrixx reports Q2 decline but hopes new campaign will boost business
SCOTTSDALE, Ariz. Matrixx Initiatives on Monday reported a decline of 17% in net sales to $21.3 million for the company’s second quarter ended Sept. 30. The decline, Matrixx president and CEO Bill Hemelt explained to analysts Tuesday morning, represented a course correction of sorts. The sales decline was “due to lower upfront buys by retailers,” Hemelt said. Last year, all of the hype around H1N1 drove retailers to heavily stock in cough-and-cold supplies. This year, that industry level has dropped to more historical levels, Hemelt suggested, particularly across the drug channel.
Hemelt shared with analysts the company’s new advertising campaign, which begins airing in earnest a week following the November elections. The new campaign features three iconic TV moms — "The Brady Bunch’s" Florence Henderson, "Family Ties’" Meredith Baxter and "Seinfeld’s" Estelle Harris — who make up the “Mom Squad” and save cold sufferers from various treatment myths, such as “freezing out” a cold or consuming onions to help relieve the cold.
“We believe our new creative will continue to differentiate our products from general symptom relief products and help increase consumer awareness,” Hemelt said. “All of these [initiatives] will be supported by strong retail marketing support that has already begun,” Hemelt added during his conference call with analysts.
Last week, Matrixx released a new national survey of U.S. adults that found the majority of Americans are misinformed about what causes the common cold, and how and when they should treat it. Nearly three-quarters of consumers (72%) believed there was not much they could do about a cold except mask the symptoms and wait it out. The top five myths about colds that pharmacists reported were most difficult to debunk:
- Antibiotics can kill the germs that cause colds;
- Changes in the weather can cause colds;
- Getting wet and chilled can cause colds;
- Sitting in a draft can cause colds; and
- Avoiding changes in temperatures will help prevent colds.
Strativa enters license, supply agreement with Sobi
WOODCLIFF LAKE, N.J. Strativa Pharmaceuticals is working with a Swedish drug maker to develop and commercialize a prescription vitamin supplement, Strativa said Tuesday.
The company said it had signed a license and supply agreement with Swedish Orphan Biovitrum, also known as Sobi, concerning European rights to Strativa’s Nascobal (cyanocobalamin), a vitamin B12 nasal spray.
The supplement is approved for treating vitamin B12 deficiency, designed as a once-weekly alternative to injections. Vitamin B12 deficiency usually results from pernicious anemia, a strict vegetarian diet and poor absorption of the nutrient resulting from such medical conditions as HIV infection, Crohn’s disease, multiple sclerosis and gastrectomy.