PAUL N. BROWN, District Judge:
Dey Laboratories, Inc. (Dey) appeals from a summary judgment. In granting summary judgment the district court held that the atropine sulfate inhalant manufactured and marketed by Dey is a "new drug" under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301-392 (the Act). The district court was correct in holding that as a matter of law "any consensus which may exist regarding the safety or efficacy of [Dey's] ASI is not...
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