Regulatory and Washington

SILVER SPRING, Md. — U.S. marshals have seized more than $6 million in products distributed by Triad Group at the company’s facility in Hartland, Wis., the Food and Drug Administration reported Wednesday.

“We took this action to stop Triad from continuing to distribute products [that] may pose a risk to public health,” stated Dara Corrigan, FDA associate commissioner for regulatory affairs.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Wednesday recommended that DSE Healthcare Solutions, which markets both Cystex urinary pain relief tablets and Cystex liquid cranberry complex with Proantinox, modify its advertising to better distinguish the two products.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by AstraZeneca for treating a rare form of thyroid cancer, the agency said.

The FDA announced the approval of the daily pill vandetanib for late-stage medullary thyroid cancer in patients whose disease is growing and causing symptoms but who are ineligible for surgery.

Medullary thyroid cancer involves specific cells found in the thyroid gland and can occur spontaneously or be part of a genetic disease. There currently are no FDA-approved treatments for this cancer.

SPRINGFIELD, Ill. — Illinois Circuit Judge John Belz on Tuesday ruled that Illinois pharmacists could refuse to dispense the emergency contraceptive Plan B, despite a 2005 edict that required pharmacists to dispense Plan B, regardless of their religious beliefs, according to published reports.

ARLINGTON, Va. — The Center for Healthcare Supply Chain Research, the research foundation of the Healthcare Distribution Management Association, on Tuesday released “Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chain,” the first comprehensive research study analyzing the impact of REMS programs across the healthcare supply chain.

ALEXANDRIA, Va. — The Centers for Medicare and Medicaid Services announced this week it would delay implementation of its proposed Medicare Part D long-term care “short-cycle” rule for one year.

DUBLIN — British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

Shire announced Wednesday that it had filed the suit in the U.S. District Court for the Southern District of New York against Watson and several subsidiaries over their attempt to market a generic version of Adderall XR (amphetamine, dextroamphetamine mixed salts) and breach of contract.

HAYWARD, Calif. — Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

Impax said Tuesday that it had filed an approval application with the Food and Drug Administration for dexlansoprazole delayed-release capsules in the 30-mg and 60-mg strengths. The drug is a version of Takeda’s Dexilant.