HEALTH

FDA commissioner Hamburg invited to testify at Tylenol recall hearing

BY Michael Johnsen

WASHINGTON The House of Representatives Committee on Oversight and Government Reform chairman Ed Towns, D-N.Y., on Tuesday added Food and Drug Administration commissioner Margaret Hamburg to the list of executives invited to testify during the committee’s upcoming Tylenol recall hearing.

Johnson & Johnson chairman and CEO Bill Wildon has also been invited to testify.

The committee plans to hold the hearing May 27 at 10 a.m.

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Axellia acquires OTC maker

BY Michael Johnsen

COPENHAGEN Axellia Pharmaceuticals on Tuesday announced its acquisition of the Phoenix Global Supply Group, based in White Plains, N.Y., to supply over-the-counter topical anti-infectives to the U.S. and Canadian markets.

“An important part of our strategy is to expand our offering to include finished products in targeted dosage forms and geographic markets,” said Axellia CEO Carl-Ake Carlsson, “while continuing to develop our core active pharmaceutical ingredients business.”

Phoenix’s initial product launches in North America are expected to include private-label offerings around bacitracin and polymyxin B sulfate, two of the major ingredients found in topical anti-infective first aid products.

“The Phoenix team is delighted to welcome Axellia as its majority owner. While there are many other manufacturers of over-the-counter antibiotic products, we believe that the U.S. and Canadian markets for these products continue to be attractive and provide a significant opportunity for Phoenix,” stated Walter Jenkins, Phoenix CEO.

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NAD recommends InflameAway Celadrin ad claims be discontinued

BY Michael Johnsen

NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Wednesday recommended that Imagenetix discontinue certain advertising claims made for the dietary supplement InflameAway Celadrin following a challenge by Schiff Nutrition Group. InflameAway executives countered that they did not agree with the decision, but agreed to abide by NAD’s suggestions.

Imagenetix, at the outset of the NAD review, informed the bureau that the company had been revising its marketing campaign prior to the NAD challenge and had discontinued all of its comparative claims versus glucosamine/chondroitin (and other joint health products), as well as its claim that Celadrin has been “proven to work.”

NAD advised Imagenetix to also discontinue the claim that Celadrin is “clinically tested and shown to be effective for improving joint comfort” as the evidence in the record was inconsistent and insufficient to support a claim that either Celadrin, or its active ingredient, cetylated fatty acid, had been proven effective through clinical trial.

Further, NAD noted, while the patent on the ingredient is evidence of its novelty, the patent alone cannot support a “clinically shown” claim. NAD recommended that the advertiser discontinue the claim.

NAD also found that the claim that “patented InflameAway Celadrin is a medical breakthrough,” was not supported by the research on Celadrin or by the patent on the key ingredient in Celadrin and recommended that it be discontinued.

InflameAway, in its advertiser’s statement, said it is “extremely disappointed that the unrebutted opinions of two highly qualified scientific experts have been rejected in favor of the non-scientific judgment made by NAD counsel.”

However, in the spirit of cooperation, the company said it “has and will continue to voluntarily discontinue the use of all NAD challenged claims in its national advertising.”

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