Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration on Thursday posted a notification to healthcare professionals and patients that the agency continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products, which are available as a spray, gel and liquids sold over the counter. Benzocaine products are used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

ALEXANDRIA, Va. — Texas policymakers seeking to contain Medicaid costs should utilize community pharmacists to achieve both savings and optimal health outcomes, the National Community Pharmacists Association suggested on Thursday.

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.

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.

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.

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.