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Executive Summary

J&J MAY BE HEADING INTO DANDRUFF SHAMPOO MARKET; the company recently submitted a petition asking FDA to allow an ANDA filing for a shampoo product containing omadine MDS. In the May 1 request, J&J stated that "omadine MDS [dandruff shampoo] is related to zinc omadine (zinc pyrithione) the new drug substance in the NDA approved dandruff control product, Head & Shoulders." Based on the established safety and efficacy of zinc pyrithione, which was the subject of an approved NDA in 1967, J&J is asking that omadine MDS be evaluated without the animal and clinical studies required for a new drug. "It is reasonable to conclude that omadine MDS is, in essence, the magnesium salt of pyrithione, the active moiety in the approved dandruff control agent, zinc omadine, and hence should be considered an acceptable candidate for submission as an ANDA," the May 1 filing maintains. J&J has a total of five ANDA petitions pending at FDA. McNeil has requests pending for chlorzoxazone (250 mg) and aspirin (325 mg) in tablet formulation; for methocarbamol (400 mg) and acetaminophen (325 mg) also in tablet formulation; and for ibuprofen (200 mg) with codeine phosphate (30 mg and 60 mg) in capsule and/or tablet form. In addition, Ortho has filed for ANDA eligibility of a triphasic oral contraceptive identical to its currently marketed Ortho-Novum 7/7/7 tablets except for a higher proposed dosage regimen.

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