FDA extends Momenta drug review

Momenta Pharmaceuticals Inc. said today the Food and Drug Administration's review of its generic anti-blood clotting drug M-Enoxaparin is likely to take longer than it expected.

The news sent shares tumbling $1.67, or nearly 15 percent, to $9.65 in premarket trading, having closed Wednesday at $11.32. The stock is now indicated to open below its 52-week low of $10.40.

M-Enoxaparin is the generic version of Sanofi-Aventis' Lovenox. Momenta filed an abbreviated new drug application for the generic on Aug. 29, 2005, but said the review will probably last longer than the range of 18 to 24 months it originally expected. It did not say when it expects the process to end.

Momenta describes M-Enoxaparin as its most advanced product candidate. It said the review is progressing "satisfactorily," but the timing of parts of the review has changed. The company is developing the drug with Sandoz Inc., the generics unit of Novartis AG. (AP)