FDA Approved Possibly Harmful Generic Acetadote, Suit Says

Law360, New York (November 15, 2012, 4:00 PM EST) -- Cumberland Pharmaceuticals Inc. on Tuesday moved to block the U.S. Food and Drug Administration's approval of InnoPharma Inc.'s generic version of Cumberland's acetaminophen-overdose treatment Acetadote, claiming the approval could put potentially harmful versions of the drug on the market.

In a complaint filed in Washington federal court, Cumberland claims the FDA approved InnoPharma's generic version of Acetadone containing edetate disodium, or EDTA, after directing Cumberland to evaluate the feasibility of removing EDTA from the drug due to potential safety concerns over the ingredient.

Cumberland eventually removed...
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Case Title

CUMBERLAND PHARMACEUTICALS INC. v. FOOD AND DRUG ADMINISTRATION et al


Case Number

1:12-cv-01842

Court

District Of Columbia

Nature of Suit

Administrative Procedure Act/Review or Appeal of Agency Decision

Judge

Reggie B. Walton

Date Filed

November 12, 2012

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