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Executive Summary

COPLEY SHIPMENTS OF ALBUTEROL SOLUTION SET TO BEGIN BY FEB. 1 following D.C. Federal Court Judge Michael Boudin's Jan. 17 decision to grant Copley Pharmaceuticals' intervenor motion for summary judgment and deny Schering-Plough's request for a preliminary injunction in a lawsuit against FDA. If Schering's Dec. 16 request had been granted, the court would have enjoined FDA's Nov. 27 ANDA for Copley's albuterol sulfate 0.5% solution for inhalation, the first approved generic version of Schering's Proventil and Glaxo's Ventolin. Schering's Dec. 16 preliminary injunction request questioned FDA's authority to approve generic versions of albuterol solutions, which are nonsystemically absorbed, without meeting the statutory definition of bioequivalence ("The Pink Sheet" Dec. 23, T&G-13). At FDA's request, Copley had agreed not to market its albuterol product until Jan. 13. The agency made the request because it had promised Schering that it would give the company 10-day's notice prior to any albuterol ANDA approvals as part of Schering's ongoing litigation over generic albuterols. FDA did not give Schering prior notice of Copley's Nov. 27 approval and subsequently asked Copley to delay marketing. The D.C. federal court concluded that "FDA's interpretation [of bioequivalence] is consistent with the language of the [Food, Drug & Cosmetic Act] and with its legislative history." Upon review of the language, the structure and the legislative history of Section 355(j)(7)(B) of the FD&C Act, Judge Boudin concluded that the section "must be interpreted to mean what it says and nothing more: a drug shall be considered to be bioequivalent to an approved drug whenever either of the two showings set forth in that section is met." "Thus," Judge Boudin wrote, "the plain language" of the section, "when read in light of the statute as a whole," itself provides sufficient support for the FDA's decision to deny the Schering petition. "Moreover, not only" does the section "fail to rule out the possibility that other showings might be used to establish bioequivalence" in the eyes of FDA, "another section [Section 355 (j)(6)(A)(i)(III)] affirmatively suggests that they may," Judge Boudin's decision states. The court's decision also dismisses Schering's original complaint. The dismissal allows Schering the option of filing a future legal challenge to FDA's ANDA approval of Copley's albuterol based on the agency's administrative record, which is not yet fully assembled, but the decision does not appear to leave Schering much room for maneuvering. Copley has a related action pending in D.C. federal court against Schering, which, the court notes, alternatively could be used as a vehicle for obtaining judicial review of the Copley albuterol ANDA approval. Copley was represented in the case by attorney Alvin Lorman (D.C. office of Akin, Gump, Hauer & Feld). Schering was represented by Robert Reznick (D.C. office of Hughes, Hubbard & Reed).

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