Zuckerman Spaeder LLP Helps Win Pivotal FDA Victory for Biotech Company

Zuckerman Spaeder LLP is pleased to announce that the U.S. District Court for the District of Columbia has upheld a critical U.S. Food and Drug Administration (FDA) approval involving Zuckerman Spaeder client Momenta Pharmaceuticals (Momenta). In Sanofi-Aventis v. Food and Drug Administration et al., No. 10-cv-1255, the court ruled that the FDA acted within its authority to approve a generic version of the blood thinner Lovenox® (active ingredient enoxaparin sodium injection). The generic product is produced using Momenta’s technology, and is marketed and sold by Sandoz, Inc.

In 2010, Sanofi-Aventis sued for a preliminary injunction to block the FDA from approving the generic enoxaparin product. The district court denied the injunction request. Sanofi-Aventis subsequently moved for summary judgment against the FDA, which cross-moved for summary judgment. Momenta’s business partner, Sandoz, intervened as a defendant at the preliminary injunction stage and also cross-moved for summary judgment after Sanofi’s injunction request was denied. The court granted the FDA’s and Sandoz’s cross-motions and denied Sanofi’s motion.

Zuckerman Spaeder partner Carlos Angulo assisted Sandoz, on behalf of Momenta, with food and drug, and administrative law matters related to the briefs and oral arguments at both the preliminary injunction and summary judgment stages. At each of these stages, the court rejected Sanofi’s arguments that the FDA acted outside the bounds of its statutory authority to approve the Momenta/Sandoz generic product.

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