Lanham Act covers ads that drug is FDA-approved/has ANDA

Arbor Pharmaceuticals, LLC v. ANI Pharmaceuticals, Inc., 2018 WL 3677923, No. 17-4910 (D. Minn. Aug. 2, 2018)Arbor sells prescription erythromycin ethylsuccinate for oral suspension, allegedly the only FDA-approved products of their kind on the market. ANI announced the launch of its own erythromycin ethylsuccinate for oral suspension, allegedly claiming to be a generic version of Arbor’s products and falsely claiming FDA approval/AB-rating pursuant to an approved Abbreviated New Drug Application (ANDA). A product similar to an NDA-approved drug may be approved and marketed based on an ANDA, which requires a showing of therapeutic equivalence; the resulting AB-rating communicates that the product is a true generic. Arbor alleged that ANI acquired an ANDA from another pharmaceutical company for a discontinued product that had been manufactured using a process that differs from that used by ANI, and that the FDA has notified ANI that its application wasn’t approvable.…

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