Regulatory and Washington

SILVER SPRING, Md. — Fake versions of a cancer drug made by Roche's U.S. unit have entered the United States, the Food and Drug Administration warned Wednesday.

The FDA advised healthcare professionals and patients that a counterfeit version of Genentech's Avastin (bevacizumab) had been distributed in the United States. The agency said the counterfeit versions carried Roche's logo instead of Genentech's and displayed batch numbers starting with B6010, B6011 or B86017.

NEW YORK — The Food and Drug Administration will review a regulatory approval application from Pfizer for a drug to treat an extremely rare and fatal degenerative disease, Pfizer said Wednesday.

Pfizer announced that the FDA had accepted its application for tafamidis meglumine, a treatment for transthyretin familial amyloid polyneuropathy. The disease, also known as TTR-FAP, is a fatal genetic illness that affects about 8,000 people worldwide and causes severe sensory loss, pain, weakness and organ dysfunction.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Monday reported Direct Digital, marketer of Instaflex, has supported certain advertising claims made in print and online.

Instaflex is formulated with 1,500 mg glucosamine sulfate, 500 mg methylsulfonylmethane, 250 mg ginger root extract and 4 mg hyaluronic acid. Direct Digital had claimed that Instaflex could relieve and comfort joints and increase flexibility, among other claims.

PITTSBURGH — Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

Sunovion Pharmaceuticals sued Mylan and several subsidiaries in the U.S. District Court for the District of Delaware when the latter sought to market a generic version of Sunovion's Xopenex (levalbuterol hydrochloride) inhalation solution, a drug for asthma and chronic obstructive pulmonary disease. The jury's verdict includes an $18 million award.

WASHINGTON — The National Consumers League, the National Association of Chain Drug Stores Foundation and the American Association of Colleges of Pharmacy have recognized five pharmacy schools for their public education efforts to help patients adhere to their medication routines.

FOSTER CITY, Calif. — The Food and Drug Administration is giving priority review to a drug made by Gilead Sciences that the company is investigating for the prevention of HIV.

Gilead said the FDA gave the special designation to its application for Truvada (emtricitabine and tenofovir disoproxil fumarate) for pre-exposure prophylaxis, or PrEP, to reduce the risk of HIV infection. The FDA originally approved Truvada for treating HIV infection in 2004, and it is currently the most prescribed antiretroviral drug in the United States.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Monday recommended that Barlow Herbal Specialties discontinue advertising its LDM-100 dietary supplement as a "plant or herb antibiotic."

In its advertising statement, Barlow agreed to discontinue the challenged claims. However, a video embedded on the company's website as of Feb. 14 touted LDM-100 as an "antiviral" and "antifungal" good for use during cold and flu season.

WASHINGTON — The Obama administration will not make any additional changes to its rule that will mandate health insurance plans to provide free contraception to women, despite reports of a compromise with those that were against the requirement.