Regulatory and Washington

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.

ALEXANDRIA, Va. — In anticipation of Earth Day 2011 on April 22, the National Community Pharmacists Association is encouraging community pharmacists to demonstrate their role as a respected and knowledgeable resource on all aspects of medications, from dispensing to disposal, the association announced Thursday.

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. — 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.

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.

PITTSBURGH — Mylan subsidiary Bioniche Pharma has launched an injectable treatment for a rare metabolic disorder, Mylan said Tuesday.

Mylan announced the launch of octreotide acetate injection in prefilled syringes, a generic version of Novartis’ Sandostatin, used to treat the disorder acromegaly and suppress or inhibit severe diarrhea related to certain tumors. Acromegaly results from excess growth hormone produced in the pituitary gland, causing fatigue and weakness, body odor and carpal tunnel syndrome.