Regulatory and Washington

ALLEGAN, Mich. — Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.

Zantac 150 has annual sales of approximately $110 million, as measured by SymphonyIRI Group, Perrigo reported.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Tuesday endorsed the Community Pharmacy Fairness Act of 2011 (H.R. 1839), legislation recently introduced in the House of Representatives by Rep. Anthony Weiner, D-N.Y.

If passed, the bill will create a more competitive marketplace for the delivery of pharmacy services by enhancing the ability of independent community pharmacies to negotiate with pharmacy benefit managers, the association stated.

WASHINGTON — The philanthropic arm of the American Pharmacists Association has appointed a new executive director.

The APhA Foundation announced Tuesday the appointment of Mindy Smith, who will lead the foundation’s operations, research objectives and strategic direction, providing support and guidance to the board of directors and monitoring pharmacy trends. Smith currently is CEO of the Arizona Pharmacy Alliance and previously served as executive director of the Wyoming Pharmacy Association.

SILVER SPRING, Md. — A Food and Drug Administration panel will discuss findings in a clinical trial that has raised concerns about the safety and efficacy of Abbott's cholesterol-lowering drug when it’s combined with similar drugs, according to an FDA announcement.

SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers about a counterfeit product represented as "ExtenZe," which is the name of an authentic dietary supplement for male sexual enhancement.

The counterfeit product looks similar to the actual product, but either contains tadalafil, or a combination of tadalafil and sildenafil, all active ingredients in FDA-approved prescription medicines for erectile dysfunction.

WASHINGTON — The American Pharmacists Association is marking Older Americans Month by urging seniors to increase their knowledge about medications and wellness by talking to their pharmacists, the group said Monday.

NEW YORK — State lawmakers in New York have introduced legislation that would require simplifying and translating medication labels and providing oral interpretation services.

SILVER SPRING, Md.— The Food and Drug Administration has approved a new treatment for chronic hepatitis C, the agency said Friday.

The FDA announced the approval of Merck’s Victrelis (boceprevir) for patients with the disease. The drug is designed for patients who still have some liver function and have not previously received treatment for chronic hepatitis C infection or have failed previous treatments. The drug is approved for use in combination with the generic drug ribavirin and pegylated interferons, biotech drugs used for treating the disease.