Regulatory and Washington

NEW YORK — Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

The San Francisco Business Times reported Tuesday that Genentech, part of Swiss drug maker Roche, is appealing the FDA’s plan to revoke approval for the drug Avastin (bevacizumab) as a first-line treatment for advanced HER2-negative breast cancer in combination with paclitaxel chemotherapy.

POINT RICHMOND, Calif. — Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

Transcept sent in its application for Intermezzo (zolpidem tartrate), a pill placed under the tongue for treating patients who awake in the middle of the night and have difficulty falling asleep again.

WASHINGTON — The National Retail Federation announced that it has urged the House to support a vote to repeal last year’s healthcare-reform law, saying the measure already has begun to discourage job creation and should be replaced with legislation that reduces healthcare costs while protecting jobs.

ALEXANDRIA, Va. — A group representing the drug retailing industry submitted a letter to the House Committee on Oversight and Government Reform chairman, Rep. Darrell Issa, R-Calif., regarding "issues [that] are of the utmost importance" to its members.

The National Association of Chain Drug Stores' president and CEO, Steve Anderson, wrote to Issa, highlighting certain pieces of legislation that affect traditional drug stores, supermarkets and mass merchants with pharmacies, all of which NACDS represents.

PITTSBURGH — The Food and Drug Administration has approved a generic diabetes drug made by Mylan, the drug maker said Tuesday.

Mylan announced the approval of acarbose tablets in the 25-mg, 50-mg and 100-mg strengths. The drug is a version of Bayer’s Precose, used with diet and exercise to improve glycemic control in adults with Type 2 diabetes.

The drug had sales of around $23 million during the 12-month period ended in September, according to IMS Health.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for head lice, the agency said Tuesday.

The FDA approved Natroba (spinosad) topical suspension, made by ParaPro, a privately owned drug company based in Carmel, Ind. The drug is used to treat head lice infestation in patients ages 4 years and older.

NEW BRUNSWICK, N.J. — After announcing its voluntary recall of certain products at a wholesaler level on Friday, Johnson & Johnson's McNeil Consumer Healthcare division provided an update on its internal assessment phase of its comprehensive action plan.

LONDON — A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

The drug maker recently announced that the Food and Drug Administration asked AstraZeneca to submit a Risk Evaluation and Mitigation Strategy, which accordingly extended the Prescription Drug User Fee Act from Jan. 7 to April 7.

AstraZeneca will continue to work closely with the FDA to support the review of vandetanib, a drug for treating patients with advanced medullary thyroid cancer.