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This article was originally published in The Tan Sheet

Executive Summary

DEL TO REFORMULATE STYE AS OPHTHALMIC EMOLLIENT OINTMENT by dropping yellow mercuric oxide 1% (YMO) and adding mineral oil and petrolatum as active ingredients, the company said. Del Pharmaceuticals told FDA in an April 7 letter that it "will remove YMO from its currently marketed anti-infective ophthalmic ointment, and reformulate and relabel the product as an ophthalmic emollient ointment under the" OTC ophthalmic drugs monograph. Stye ointment with YMO is currently marketed for the treatment of blepharitis. The reformulated product is expected to be called Stye Lubricant Eye Ointment. Del petitioned FDA in January to stay the effective date of a Dec. 18, 1992 final rule, which found that no active ingredients are generally considered to be safe and effective for OTC use as ophthalmic anti-infectives, including YMO. In the petition, Del argued that the rule's effective date of June 18 to remove products from the market should be delayed to give the agency enough time to review the results of a YMO clinical trial conducted by the company and being prepared for submission to FDA ("The Tan Sheet" March 1, p. 12). The trials were intended to support the ingredient's inclusion in the OTC ophthalmic products final monograph as an anti-infective ingredient. "In light of results" of the company's clinical studies on the safety and effectiveness of YMO, Del said it "no longer intends to petition FDA to amend the ophthalmic monograph to include YMO as an anti-infective ingredient," and instead will reformulate the product, the letter states. However, Del continues to ask for a six-month extension of the final rule's effective date from June 18. "Rather than being premised on the need to allow time for FDA to review new clinical data on the safety and efficacy of YMO, that request is now premised on the need to allow sufficient time to relabel and reformulate Del's OTC ophthalmic ointment as an emollient in conformity with the ophthalmic monograph," the firm told FDA. Del explained that additional time is needed so that the reformulation can be "prepared, assayed, and subjected to identity and stability testing." Also, the company noted, "contracts must be concluded for supply of both components and raw materials, with lead times of up to four months, and for manufacture of the finished product." In addition, "new labeling for cartons and tubes must be designed, checked and printed, and new cartons and tubes must be manufactured," Del said. The company pointed out that "in view of these exigencies, FDA normally gives manufacturers 12 months following" publication of a final notice to bring their products into conformity with the monograph. "Here, of course, Del is reformulating and relabeling its product not to conform it to the terms of the Dec. 18 rule on anti-infectives per se, but rather to another portion of the ophthalmic monograph," Del maintained. The company pointed out that it "is reformulating its product in response to the Dec. 18 rule and the results of the company's clinical studies." The letter notes that the "damage that would be done to Del by an interruption in the company's ability to ship product after June 18, including lost sales and disruption of long-standing trade and consumer relationships, . . . would not be any less under the new circumstances." Because Stye as currently formulated will be coming off the market, the firm continued, "the damage resulting from a premature cessation of shipments would be compounded by the need to write off substantial amounts of excess stock of the current product." Six months would allow Del to use up existing inventory of Stye and "make an orderly transition to the new product," the company told FDA. Moreover, the public health would not be adversely affected if Stye was allowed to remain on the market for an additional six months, Del argued, since "the current product has been marketed for nearly 40 years, with an infinitesimal incidence of adverse reactions in approximately 20 mil. tubes sold, and is clearly safe." Other ophthalmic ointments on the market include Bausch & Lomb's Duolube Lubricant Eye Ointment, and Allergan's Lacri-Lube Lubricant Ophthalmic Ointment and Sterile Ophthalmic Ointment and Refresh P.M. Lubricant Ophthalmic Ointment.

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