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OTC Nicorette will be available in retail stores by late spring following Feb. 9 approval.

This article was originally published in The Tan Sheet

Executive Summary

NICORETTE GUM 2 MG AND 4 MG APPROVED BY FDA for over-the-counter marketing on Feb. 9. SmithKline Beecham said the OTC product will be available to consumers in late April/early May. The Nicorette switch unanimously cleared a joint meeting of FDA's Nonprescription Drugs and Drug Abuse Advisory Committees on Sept. 28 ("The Tan Sheet" Oct. 2, 1995, pp. 1-6). The product has been at the "approvable" stage at FDA since Dec. 12 ("The Tan Sheet" Dec. 18, 1995, In Brief). The NDA supplement has been under review at FDA since December 1994.
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