FDA is staunching a nick in its previous review of OTC astringent by moving aluminum sulfate (styptic pencils) into the Category I safe and efficacious group of ingredients. The OTC review panel's initial report on astringent had incorrectly listed aluminum sulfate among ingredients needing more testing. After reviewing the panel report and submissions, FDA determined that "a range of 46% to 63% aluminum sulfate (based on the anhydrous equivalent) is acceptable for use as a styptic pencil." FDA's proposed indication reads: "Stops bleeding caused by minor surface cuts and abrasions as may occur during shaving." In addition to aluminum sulfate, FDA also classified aluminum acetate and hamamelis water (witch hazel) as Category I astringents is a notice of proposed rulemaking published in the April 3 Federal Register. The proposed rulemaking amends the OTC Skin Protectant RFM to include standards for OTC astringent products. The skin protectant TFM was issued on Feb. 15, 1983. FDA had considered astringent drug products under both the skin protectant and external analgesic rulemakings. The TFM combines the rulemakings for both the external analgesic and skin protectant uses of OTC astringent drug products, and places the monograph for these products under the skin protectant rulemaking. "The agency has determined that the external analgesic and skin protectant uses of OTC astringent drug products are so closely related that it would not serve the public interest to proceed with two separate rulemakings for the same ingredients," FDA explained. The agency added aluminum chloride hexahydrate to the rulemaking as a Category III astringent. FDA noted that the panel had "inadvertently" failed to review a data submission on the ingredient, which the agency subsequently evaluated. The agency concluded that the data were insufficient to establish the effectiveness of aluminum chloride hexahydrate as an OTC astringent "for use as a wet dressing for relief of inflammatory conditions." The ingredient is being added to the TFM, FDA said, because "some of the references in the submission are supportive of the effectiveness of aluminum chloride hexahydrate as an astringent." The TFM proposes new final solution concentration parameters for aluminum acetate. The panel had recommended a concentration of 2.5 to 5%, with a 1:20 to 1:40 dilution ratio. Under the proposed rule, FDA clarifies that the final solution should be 0.13 to 0.5% aluminum acetate. "Depending on the formulation and concentration of the marketed product, the manufacturer must provide adequate directions so that the resulting solution to be used by the consumer contains 0.13 to 0.5 percent aluminum acetate," FDA said. The agency is also proposing to revise the panel's recommended indication for aluminum acetate to state: "'For temporary relief of minor skin irritations due to' (select one or more of the following: 'poison ivy,' 'poison oak,' 'poison sumac,' 'insect bites,' 'athlete's foot,' or 'rashes caused by soaps, detergents, cosmetics, or jewelry')" The proposed rule also revises the allowed indications for hamamelis water. The panel had included claims relating to sunburn, bruises, contusions, and sprains. But FDA explained it was removed the indications because it is not aware of any data supporting the claims. FDA's proposed indication reads as follows: "'For temporary relief of minor skin irritations due to' (select one or more of the following: 'insect bites,' 'minor cuts,' or 'minor scrapes')." The TFM also includes two Category III combinations: an external analgesic with an astringent and a skin protectant with an astringent.
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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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