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.
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.
PerformRx receives PBM accreditation from URAC
PHILADELPHIA A full-service pharmacy benefit manager received its second accreditation from an independent, nonprofit healthcare-accrediting organization.
PerformRx said that its pharmacy benefit management accreditation from URAC indicated that PerformRx’s PBM business demonstrated a commitment to quality services. “This accreditation serves as a clear sign that PerformRx is committed to providing the best possible service to our existing and future customers,” said Mesfin Tegenu, PerformRx president. “The URAC evaluation is an incredibly rigorous process that evaluates the organization at all levels, and to wear the URAC seal is a mark of distinction for our company.”
In conjunction with its PBM accreditation, PerformRx also applied for URAC’s drug therapy management accreditation. PerformRx’s DTM program improves therapeutic outcomes for members by evaluating drug dose, method of delivery, cost effectiveness and other factors, the company said, adding that obtaining the DTM accreditation will allow PerformRx to demonstrate the high quality and effectiveness of its DTM program.