Procter & Gamble will have to pursue NDA approval of triclosan as an oral antimicrobial agent before the company can introduce a toothpaste that includes the ingredient, FDA told the company in a Feb. 1 letter. P&G had planned to include the ingredient in a new toothpaste, Ultra Protection Crest. FDA explained in the letter to P&G that, "to the best of our knowledge, the ingredient triclosan has never been used in any oral cavity drug preparation previously marketed in this country, either as an active or inactive ingredient, nor has it been used in any oral cosmetic preparations marketed in this country." As a result, FDA stated, the product "is a new drug irrespective of the claims attributable to the activity of triclosan." P&G has aborted its planned March introduction of Ultra Protection Crest as a result of FDA's unyielding position on triclosan. However, despite the eleventh hour halt to the launch, P&G said it does not have to pull back ads or recall product shipments. P&G said it had not test marketed Ultra Protection Crest prior to the planned launch. However, FDA noted that the company had promoted the new toothpaste at the American Dental Association meeting last October in Boston. According to FDA, P&G promoted the new toothpaste at the ADA meeting as "effective against bacteria"; reducing "total bacteria significantly when compared with control"; and providing "Bacteria Reduction along the Gingival Margin." In a Dec. 6 letter, FDA informed P&G that Ultra Protection Crest would be considered a drug because the firm's "fights bacteria" claim is a drug claim. FDA discounted P&G's protests that the product would be promoted as an antimicrobial agent "to fight bacteria that cause bad breath" and result in "a cleaner, healthier mouth." FDA stated: "Except for the reference to a cleaner, healthier mouth, there is nothing in the label to indicate that the product has any cosmetic indications. Without any qualification on the use of the antimicrobial ingredient, we can only conclude . . . that the antimicrobial activity is intended for drug use." Triclosan is currently listed as a Category III antimicrobial ingredient for use in creams, soaps, diaper rash products and surgical scrubs. It is the active ingredient in such products as Dial Liquid Anti-Bacterial Soap and Almay Anti-Bacterial Foaming Cleanser. P&G may still choose to file an NDA in support of OTC use of triclosan as an oral antimicrobial. A possible advantage to doing clinical trials and filing an NDA for a toothpaste that includes triclosan is the possibility of winning three years of exclusive marketing of the ingredient for that use under the Waxman/Hatch Act. However, the company apparently does not have a choice if it is set on using the ingredient in a toothpaste. FDA indicated that P&G would not be able to use the monograph route to make the ingredient available as an oral OTC ingredient since any oral use would be unprecedented in the U.S. Both P&G and FDA said they were unaware of any previous use of triclosan in an oral antimicrobial or antiplaque product. However, several firms do market toothpastes with triclosan abroad, including P&G, which markets triclosan-containing toothpastes in Italy, Sweden, the U.K., Mexico, Greece, Venezuela, Saudi Arabia and Chile, among others. Colgate-Palmolive reportedly had plans to launch its own triclosan-containing toothpaste, Colgate Gum Protection Formula in the U.S.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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