- Jul 16, 2001
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A pharmaceutical company that seeks federal approval for over-the-counter sales of a prescription diet pill that blocks the absorption of fat faces questions on the pill's potential for creating vitamin deficiencies and encouraging abuse.
Two Food and Drug Administration advisory committees are to discuss on Monday allowing over-the-counter sales of orlistat, which GlaxoSmithKline Consumer Healthcare proposes to market as Alli (pronounced "ally"). That version would be half the dose of the prescription form of the drug, known as Xenical, which won FDA approval in 1999.
An FDA reviewer found the drug is a "safe and effective weight loss agent," but held off on recommending whether the Nonprescription Drugs and the Endocrinologic and Metabolic Drugs advisory committees should in turn recommend to the FDA that it approve the drug for sale without a prescription.
A pharmaceutical company that seeks federal approval for over-the-counter sales of a prescription diet pill that blocks the absorption of fat faces questions on the pill's potential for creating vitamin deficiencies and encouraging abuse.
Two Food and Drug Administration advisory committees are to discuss on Monday allowing over-the-counter sales of orlistat, which GlaxoSmithKline Consumer Healthcare proposes to market as Alli (pronounced "ally"). That version would be half the dose of the prescription form of the drug, known as Xenical, which won FDA approval in 1999.
An FDA reviewer found the drug is a "safe and effective weight loss agent," but held off on recommending whether the Nonprescription Drugs and the Endocrinologic and Metabolic Drugs advisory committees should in turn recommend to the FDA that it approve the drug for sale without a prescription.
