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Del Pharmaceuticals

This article was originally published in The Tan Sheet

Executive Summary

FDA denies firm's request for a six-month extension of June 18 effective date of the final rule requiring all OTC ophthalmic anti-infectives to be removed from the market. In response to the final rule published last December, Del decided to reformulate its Stye ophthalmic ointment by dropping yellow mercuric oxide 1% and adding mineral oil and petrolatum. Del had asked FDA for an extension to allow sufficient time to reformulate and relabel the product ("The Tan Sheet" April 19, p. 11)
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