HEALTH

Court upholds Perrigo claim to market generic Pepcid

BY Michael Johnsen

WASHINGTON The U.S. Court of Appeals for the Federal Circuit last week affirmed a lower court’s decision in June 2007 that opened the door to Perrigo’s store brand version of McNeil Consumer’s Pepcid Complete.

The ruling enables Perrigo to begin shipping the heartburn reliever in the third quarter of this year, according to published reports.

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ADA petitions FDA to crack down on natural weight-loss claims

BY Michael Johnsen

CHICAGO The American Dietetic Association last week filed a joint citizen’s petition to the Food and Drug Administration regarding the weight-loss claims made by marketers of dietary-supplement-containing diet aids.

“The American Dietetic Association this week is joining with three other groups in asking the U.S. Food and Drug Administration to raise the scientific standard bar for weight-loss supplement health claims,” the ADA noted in its weekly online newsletter published Friday.

The groups, which filed the petition April 17,  are asking the FDA for changes in the regulation of weight-loss supplements so that manufacturers would be required, on the basis of credible scientific evidence, to obtain prior FDA approval of weight-loss claims.

Traditionally, regulating weight-loss claims made in advertising has fallen under the purview of the Federal Trade Commission. That would change, however, if the FDA were to rule that weight-loss claims are a disease state claim, as the citizen’s petition argues.

The ruling could weaken the ability of makers of natural diet aids to market their products to consumers, stacking the deck in favor of GlaxoSmithKline’s over-the-counter medicine weight-loss drug Alli, the one brand that would still be able to make weight-loss claims under those restrictions.

The move would potentially drive more of the $180.3 million in diet aid tablet sales that Alli doesn’t already control into GSK’s bucket. According to Information Resources Inc., Alli alone generated sales of $118.9 million for the 52 weeks ended Jan. 27, across food, drug and mass channels (excluding Wal-Mart), accounting for 32.2 percent of all dollars spent in the category and 13 percent of all units purchased.

GSK, according to the ADA report, is one of the companies that has signed the petition. The other petitioners are Shaping America’s Health and the Obesity Society.

The general public already assumes the FDA is governing dietary supplement diet aid claims, the ADA claims. According to ADA statistics, some 34 percent of consumers have used weight-loss products, and 46 percent believe that the FDA regulates natural diet aids for efficacy, which it does not.

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Perrigo files FDA application for OTC generic of Monistat

BY DSN STAFF

ALLEGAN, Mich. Perrigo on Monday announced that it has filed an abbreviated new drug application for over-the-counter miconazole nitrate vaginal cream, 2 percent and Suppository, 1.2g, a generic version of Monistat 1 Combination Pack.

Monistat 1 Combination Pack is an antifungal medication indicated for the treatment of vaginal yeast infections, and had sales of approximately $50 million through food, drug and mass merchandisers for the 12 months ended March 2008, as measured by Information Resources, Inc., Perrigo reported.

According to Perrigo, McNeil challenged Perrigo’s ANDA with a suit filed Friday alleging patent infringement in the United States District Court for the District of New Jersey to prevent Perrigo from proceeding with the commercialization of its product. 

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