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BARRE-NATIONAL's REFORMULATED OTC EPINEPHRINE MIST

This article was originally published in The Tan Sheet

Executive Summary

BARRE-NATIONAL's REFORMULATED OTC EPINEPHRINE MIST will be launched in the fourth quarter of 1993 following FDA's recent approval of an ANDA supplement, company parent A.L. Labs announced on May 6. The product has been off the market since a December 1989 recall. The ANDA supplement for the generic version of Whitehall's Primatene Mist and Sterling Winthrop's Bronkaid Mist was filed in 1990. The primary market for the epinephrine mist .5% will be to major food and drug chains and mass merchandisers for their private label lines. The product also will be sold through other distribution channels under the Barre name. "Barre's product is the only approved generic equivalent of the over-the-counter brands, Primatene Mist and Bronkaid Mist, which together have annual sales exceeding $ 50 mil.," A.L. Labs stated. Barre-National said that Primatene Mist was the reference drug in the firm's ANDA. The generic firm said that before epinephrine mist was withdrawn from the market in late 1989, the product was generating annual sales of approximately $ 4 mil. In a Class II recall in early December 1989, Barre recalled over 1.2 mil. units of epinephrine mist because the product's potency was not guaranteed through the expiration date. The epinephrine recall was one of several recalls initiated by the firm in 1989 following a series of FDA inspections of the company's facilities from March to June as part of the agency's crackdown on the generic drug industry. In July 1992, Barre-National signed a consent decree with FDA stipulating that the firm undergo periodic audits by "an independent regulatory consultant" through 1995. The audits are intended to verify that Barre's Baltimore facility conforms with good manufacturing practices, and that the company "reconfirm the expiration dates of each of its products using statistical methods and procedures approved by FDA." Barre satisfactorily completed its first audit last year. Barre-National was acquired by A.L. Labs from Revco Drug in 1987.
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