Regulatory and Washington

WASHINGTON — Proclaiming the potential cost-saving benefits of its signature legislative accomplishment, the massive health-reform bill enacted earlier this year, the White House is projecting that the Affordable Care Act will reduce average costs per patient enrolled in Medicare by thousands of dollars over the next decade.


PRINCETON, N.J. — The Food and Drug Administration has accepted for review a supplemental approval application for an arthritis drug made by Bristol-Myers Squibb, the drug maker said Monday.

Bristol is seeking approval for Orencia (abatacept) injected into the skin as a treatment for adults with moderate to severe rheumatoid arthritis. The drug already is approved for intravenous injection.

WASHINGTON — The Consumer Healthcare Products Association recently named GlaxoSmithKline veteran Janet Carter-Smith chair of the CHPA Retailer Liaison Steering Committee, effective Jan. 1.

Carter-Smith will be the third chair of this committee, succeeding David Howenstine, VP customer and industry development at Pfizer Consumer Healthcare, whose term ends at the end of the year.

SCHAUMBURG, Ill. — The Food and Drug Administration has approved a generic chemotherapy drug made by Sagent Pharmaceuticals, Sagent said Thursday.

The FDA approved topotecan hydrochloride for injection, a version of GlaxoSmithKline’s Hycamtin. The U.S. market for injectable topotecan was around $158 million in 2010, according to IMS Health.

ATLANTA — The Centers for Disease Control and Prevention has set aside the week of Dec. 5 to observe this season's National Influenza Vaccination Week. The week-long emphasis on flu vaccination was established to highlight the importance of continuing influenza vaccination, as well as foster greater use of flu vaccine after the holiday season into January and beyond.

CAPE GIRARDEAU, Mo. (Dec. 1) Gov. Jay Nixon, D-Mo., on Tuesday campaigned for a sweeping expansion of efforts to battle methamphetamine, including legislation that would make Missouri the third state in the nation to require a prescription for the cough-cold ingredient pseudoephedrine.

It’s not a new issue for the Show Me State — several local municipalities that fall between St. Louis and the Missouri capital of Jefferson City last year passed local ordinances that required prescriptions for PSE products.

ALLEGAN, Mich. — The Food and Drug Administration has granted market exclusivity for a generic version of a medication designed to treat indoor and outdoor allergies.

Perrigo said Monday that its licensor and supplier Synthon received regulatory approval for levocetirizine tablets, a generic version of UCB/Sepracor's Xyzal, which is marketed in the United States by Sanofi-Aventis.

The levocetirizine tablet is the only approved generic product having a label containing all indications, Perrigo said.

WASHINGTON — The Institute of Medicine on Tuesday issued a report on the dietary reference intake levels for vitamin D and calcium at the behest of both the U.S. and Canadian governments. IOM recommended a slight increase in vitamin D intake, but also suggested that the need for either vitamin D or calcium may be overstated.