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Executive Summary

NEOMYCIN SULFATE/POLYMYXIN B SULFATE ANTI-INFECTIVE DERMATOLOGICAL CREAMS can be marketed OTC, FDA declared in an April 17 Federal Register notice. The products are reformulations of Rx topical creams that contain the combination with gramicidin and were classified by the agency in the DESI review as "possibly effective." The notice withdraws NDA approval of the old Rx formulation, which included products such as Burroughs-Wellcome's Neosporin-G cream. B-W has reformulated the product wighout gramicidin and will market the first-aid product OTC in May as Neosporin cream, the firm told "The Pink Sheet." Gramicidin must be removed from the cream products "because there is insufficient evidence of its safety and effectiveness, either alone or in combination," FDA explained in the notice. The DESI notice also provides for OTC marketing of topical powder and aerosol combinations containing polymyxin B sulfate and bacitracin zinc, while withdrawing NDA approval for Rx products containing the combination with neomycin sulfate. B-W, for example, already received approval for OTC marketing of the first-aid powder and aerosol reformulations. In March the firm changed the product's name, as well as formulation, from Neosporin to Polysporin ("The Pink Sheet" March 11, T&G-9). "Neomycin sulfate is removed from the aerosol and topical powder combinations . . . because of concerns about the safety of administering neomycin in these dosage forms over extensive burns or wounds, and because of the lack of evidence of its effectiveness," the notice explains. The notice also requires that steroidal Rx cream products, such as B-W's Cortisporin cream, be reformulated without gramicidin and remain Rx. The reformulated creams will contain neomycin sulfate, polymyxin B sulfate, and hydrocortisone, and their DESI classification will change from "possibly effective" to "effective." In separate DESI notices, the agency provided for the reformulation of combination creams and ointments for "cutaneous candidiasis," such as Squibb's Mycolog. The reformulated Rx drug products will contain nystatin and triamcinolone acetonide; neomycin sulfate and gramicidin, which were contained in the old combinations, must be deleted. Electro-Nucleonics, the second manufacturer to be granted FDA approval to market a diagnostic test for HTLV-III, is distributing its kit via its own sales force and Warner-Lambert's Nuclear Medical Labs Division. FDA approved the test March 7. Irving, Texas-based Nuclear Medical Labs has an exclusive contract with Electro-Nucleonics to market the kits to blood centers, plasma processors and labs world-wide. The kits will also be priced between $2 and $3, similar to the Abbott range. In anticipation of FDA approval, Electro-Nucleonics began stockpiling the ELISA-format kits, and was set to begin shipping 150,000 kits when FDA gave the go-ahead. ElectroNucleonics estimates the worldwide AIDS testing market at 70 to 80 mil. assays a year, or a minimum of $140 mil. annually. Litton-Bionetics of Kensington, Maryland, one of three companies still waiting for FDA approval under the HHS HTLV-III licensing agreement, has one mil. ELISA kits ready to distribute and is equipped to roll-out 750,000 assays per month, the firm says. DuPont and Biotech Research Laboratories also are developing AIDS virus test kits in a joint venture arrangement. DuPont is the majority partner. Under the agreement, Biotech Research will provide the technology and the production facilities while DuPont will handle marketing of the tests. Travenol-Genentech Diagnostics, a joint venture set up by Baxter Travenol and Genentech for diagnostic research, also is working on the HTLV-III test. According to a spokesman, Baxter Travenol contributed assets from its clinical assay division while Genentech provided diagnostic know-how. Fenwal Labs, a division of Baxter Travenol, will market the AIDS virus kit following approval. Outside of the original five-company HHS licensing agreement, Malvern, Pennsylvania-based Centocor expects to file an investigational new drug applicagion for its own AIDS test within the next two weeks. The company hopes to develop "an innovative second generation test which could detect more positives," Centocor told analysts in January. Centocor's test is based on the expression of viral proteins by bacteria.

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