Teva: Novartis' Sandoz unit seeks to delay first FDA approval of generic Zocor

By E. Janene Geiss

Philadelphia, June 23 - Teva Pharmaceutical Industries Ltd. said Friday that Novartis' generic unit, Sandoz, Inc., has filed a complaint in the U.S. District Court for the District of Columbia, seeking approval of its generic Zocor products in the face of an April 30 decision of the same court.

The decision in April granted Teva's motion for summary judgment on the issue of whether its abbreviated New Drug Application to market a generic version of Merck's Zocor (Simvastatin) tablets, 5, 10, 20, and 40 mgs is entitled to 180-day Hatch-Waxman statutory exclusivity, officials said in a company news release.

The court found unlawful the FDA's Oct. 24, 2005 decision denying a citizen's petition on the exclusivity issue and, accordingly, remanded the matter back to the FDA, which has since appealed to the U.S. Court of Appeals.

Teva said it is eligible to receive final approval for the 5 mg, 10 mg, 20 mg, and 40 mg strengths with exclusivity on June 23, when the product patent expires.

Sandoz has asked the court to order the FDA not to approve Teva's generic Zocor products pending a determination of its motion for a preliminary injunction ordering the FDA to approve Sandoz's aNDA.

Teva is a Jerusalem pharmaceutical company.

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