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Xenical Off-The-Market Switch Sought By Public Citizen

This article was originally published in The Tan Sheet

Executive Summary

Public Citizen is calling for prescription weight-loss drug Xenical (120 mg orlistat) to be pulled from the market days after FDA issued an "approvable" letter for an OTC version

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People In Brief

Daschle, Lambrew lead health reform office: President-elect Barack Obama formally announces his nomination Dec. 11 of former Senator Tom Daschle to head both the Department of Health and Human Services and the White House Office of Health Reform. Obama also nominates as deputy director of the White House office Jeanne Lambrew, the Office of Management and Budget's former health program associate director and co-author of Daschle's book on health care reform, "Critical." (1"The Tan Sheet" Nov. 24, 2008, p. 7). In his dual role, Daschle, who represented South Dakota in the Senate between 1987 and 2005, is expected to "be responsible, not just for implementing our health care plan, he will also be the lead architect of that plan," Obama says at a press conference. "Whether it's administering Medicare and Medicaid, keeping our food and pharmaceuticals safe, researching the cures of tomorrow, or investing in prevention and wellness, a well-functioning [HHS] can play a strong role in tackling the many health care challenges our country faces," Daschle says in accepting the nomination. Obama also praises Lambrew's health care policy and budget expertise, calling her "a leading thinker" on the issue of health reform. Lambew is currently a professor at the University of Texas' LBJ School of Public Affairs and a senior fellow at the Center for American Progress

Switch Case Study: Alli Review Contrasts OTC, Rx Division Perspectives

Every month, F-D-C Reports' Pharmaceutical Approvals Monthly dissects a new drug review by FDA. Using FDA's own review documents, including the discipline reviews, decision memos, meeting minutes, e-mails and other documents, the publication strives to illuminate the agency's decision-making process.

Alli Approved OTC For Weight Loss With “Goal Oriented” Indication

FDA's approved labeling for GlaxoSmithKline's first-in-class nonprescription weight-loss drug alli (orlistat 60 mg) emphasizes a "goal oriented" indication as opposed to a six-month duration of use as originally proposed

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