Regulatory and Washington

WOODCLIFF LAKE, N.J. — The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said Tuesday.

Eisai said the FDA had granted six more months of exclusivity for the use of Aciphex (rabreprazole sodium) in children, meaning it will lose market exclusivity on Nov. 8, 2013.

NEW YORK — A Congressional committee is looking into allegations that a compounding pharmacy industry association may have taught pharmacists how to sidestep requests for samples from the Food and Drug Administration, according to published reports.

Reuters reported that the House Energy and Commerce Committee had requested internal documents from the International Academy of Compounding Pharmacists, citing a news report about the organization.

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new use for a cancer drug made by Johnson & Johnson, the agency said Monday.

The FDA announced the approval of Zytiga (abiraterone acetate), made by J&J subsidiary Janssen Biotech, for men with castration-resistant prostate cancer that has spread to other parts of the body, for use prior to receiving chemotherapy. The drug was already approved for castration-resistant prostate cancer in men who had already undergone chemotherapy treatment.

WASHINGTON — The Campaign for Tobacco-Free Kids and other advocacy groups last week released a report claiming that states are spending only "a miniscule portion" of their tobacco revenues to fight tobacco use. "The states have failed to reverse deep cuts to tobacco prevention and cessation programs that have undermined the nation’s efforts to reduce tobacco use," the advocacy groups stated. 

 ATLANTA — The Centers for Disease Control and Prevention on Friday reported that the national incidence of influenza-like illness dropped below the national baseline of 2.2% to 1.9% and is lower than reported during the previous week. "This fluctuation may be attributed in part to a reduced number of routine health visits during the Thanksgiving holidays, as has been observed in previous seasons," the agency speculated. 

SALT LAKE CITY — Play Beverages on Friday announced that the U.S. Bankruptcy Court for the District of Utah has ruled in its favor and vacated its bankruptcy, freeing it to take legal actions to protect the product license granted for its Playboy Energy Drink.

The judge’s ruling takes Play Beverages out of an involuntary bankruptcy, enabling it to continue its action in state courts against Playboy Enterprises and others to protect its license to produce and sell Playboy Energy Drink.

BOSTON — The state health department in Massachusetts has made changes to the state's pharmacy board and leveled sanctions against three pharmacies in the wake of a nationwide meningitis outbreak traced to a compounding pharmacy in the state, the department said.