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In Brief: 1996 Rx-to-OTC switch approvals

This article was originally published in The Tan Sheet

Executive Summary

1996 Rx-to-OTC switch approvals: Pfizer's OcuHist among the major Rx-to-OTC switches cleared by the agency in 1996. Approved Jan. 31, 1996 and introduced in April, the NDA for the ocular antihistamine and decongestant with pheniramine maleate .3% and naphazoline HCl .025% was filed by Akorn June 8, 1994. With OcuHist, the agency's major approvals in 1996 totaled eight, not seven, as reported in the Jan. 20 issue of "The Tan Sheet" (p. 12). Other OTC approvals in 1996 that built on earlier switches were McNeil's Junior Strength Motrin 100 mg caplets, in June, and Whitehall-Robins' Junior Strength Advil 100 mg tablets, in December...

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