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Executive Summary

SCHERING-PLOUGH's SHADE UVAGuard SUNSCREEN APPROVED: SHIPMENTS TO TRADE will begin Dec. 29 and the company expects the product to be widely available to consumers by late February/early March. An NDA for the broad-spectrum sunscreen was cleared by FDA on Dec. 9 after a three-year review. The new UVA/UVB sunscreen, which will be marketed by the company's Plough subsidiary, contains 3% Parsol 1789 (avobenzone), 3% oxybenzone and 7.5% octyl methoxycinnamate. The product will be available over-the-counter and carries an SPF of 15. Shade UVAGuard will be the second sunscreen to be marketed in the U.S. containing Parsol 1789 under an approved NDA. Herbert Labs' Photoplex was approved in 1988. Photoplex contains 3% avobenzene and 7% padimate O, which is chemically related to PABA. Plough plans to support the launch of Shade UVAGuard with a national consumer ad campaign that will begin in the first quarter of 1993 and will include print and TV ads. The company's promotional activities will also include detailing to dermatologists. UVAGuard will be sold as a 4 oz. size lotion for a suggested retail price of $9.99, representing a substantial premium over Plough's existing Shade products, which retail in the area of $5, according to the company's 1992 sun care product guide. Photoplex is listed in the December Red Book at $8.50 (average wholesale price) and $12.75 (suggested retail price) for a 4 oz. size and $9.63 (AWP) and $14.45 (suggested retail price) for a 6 oz. size. UVAGuard is indicated for "UVB and UVA protection." FDA- approved packaging states: "While all sunscreens protect your skin from the sun's burning rays, Shade UVAGuard sunscreen, with the patented ingredient Parsol 1789, offers extra protection from the UVA rays that may contribute to skin damage and premature aging of the skin." Plough maintains that its product is the "first sun protection" formulation to combine Parsol 1789 and oxybenzone to absorb both long and short UVA rays. The formula contains octyl methoxycinnamate for UVB absorption. The firm emphasizes that UVAGuard is PABA free, which "may reduce the risk of allergic reactions." The sunscreen is not to be used "if sensitive to cinnamates, benzophenones or any other ingredient in this product." FDA states in its approval letter to the company that the agency's "clinical and statistical analyses of the clinical data submitted in the NDA demonstrated that this drug product is more irritating than those products against which it was compared." As a result, the agency continued, "any advertising and/or promotional labeling of this product will be considered false and misleading...if it presents suggestions or representations contrary to our analyses of the data submitted in this NDA regarding comparability of this product to other products." FDA also requested that Plough provide a copy of its advertising materials. The Shade UVAGuard NDA initally was filed on Dec. 1, 1989. During the course of FDA's review, Schering amended the application to include updated safety and efficacy data after receiving a "not approvable" letter from FDA on June 29, 1990. The product was deemed "approvable" by FDA on May 29, 1992 ("The Pink Sheet" July 27, p. 12). Givaudan-Roure is the supplier of Parsol 1789 for both Schering-Plough and Allergan Herbert. The UVA filter has been available overseas since 1981 and was originally introduced in the U.S. in 1984. Givaudan stopped selling Parsol 1789 in October 1986 after receiving a regulatory letter from FDA challenging the ingredient's regulatory status. The supplier has had an NDA pending for an OTC sunscreen containing 3% avobenzone and 7.5% octyl methoxycinnamate since April 1989.

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