'Switch hits' juice '07 OTC lineup

Drug Store News,  Jan 15, 2007  by Michael Johnsen

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NEW YORK -- There area number of recently switched products that are expected to reach store shelves in first quarter 2007.

The most prominent among these is GlaxoSmithKline's weight-loss drug Alli (orlistat), which received an approvable letter from the Food and Drug Administration in April. The prescription version, Roche's Xenical, generated $71.5 million in the United States for the 9 months ended in September, according to Roche, showing 15 percent sales growth.

Schering-Plough last month entered into a licensing agreement with Braintree Laboratories to market MiraLAX as a nonprescription treatment for occasional constipation. According to the company, MiraLAX was the No. 1 prescribed prescription laxative prior to the introduction of generic competition in 2004. The FDA approved the prescription-to-OTC switch of MiraLAX on Oct. 6, Schering-Plough stated. MiraLAX will begin shipping in February.

Novartis Pharmaceuticals in October announced the approval of prescription Zaditor, indicated for the temporary prevention of itchy eyes due to allergic conjunctivitis, as appropriate for sale OTC. While most OTC products provide up to 4 hours of short-term relief, Zaditor's formula offers eye itch relief that works in minutes and lasts for as long as 12 hours with one drop. Approved in 1999 for prescription use, Zaditor will be available OTC nationwide beginning this month. And last month, Alimera Sciences won approval of its prescription-to-OTC switch application for Alaway, the bioequivalent to Novartis' Zaditor.

MICHAEL JOHNSEN

SENIOR EDITOR

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