Sanofi-Aventis: Sues FDA to stop Novartis

The lawsuit filed yesterday in Washington has forced the FDA to suspend its approval of the generic produced by Novartis AG’s Sandoz unit with Momenta Pharmaceuticals Inc.’s technology. Lovenox is an injection that prevents the formation of blood clots. After the diabetes medicine Lantus, it was Sanofi’s No. 2 product last year.

Switzerland-based drug maker, Novartis, and Momenta, a biotechnology company in Cambridge, Massachusetts, had won U.S. approval for a lower-cost copy of Lovenox on July 23. This ended a five year wait to challenge the $3.9 billion-a-year product. But now, in the complaint, Sanofi has stated that the generic isn’t “clinically equivalent” to Lovenox. They also added that the FDA’s verdict could cause Sanofi “irreparable harm.”

Jean-Marc Podvin, a spokesman for Paris-based Sanofi said that the FDA’s approval “was not made in accordance with the agency’s statutory obligations,” The company “believes that this case poses a number of significant questions regarding the FDA review process for complex pharmaceutical products which are important to pursue.”

Momenta fell $3.25, or 13 percent, to $22.86 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The shares had increased 9.8 percent on July 23 and 4.4 percent yesterday in the wake of the FDA clearance of the generic drug.

A federal judge has said that the hearing on the case would be held on Aug. 17, 2010. According to a statement by Momenta, the court didn’t place any limitations on the sale of the generic drug.

A different federal judge in Washington threw out a suit Sanofi filed over the FDA’s decision to support applications for generic forms of its anti-cancer drug Eloxatin. Sanofi has settled with some of the generic-drug companies. It has obtained a court order stopping Sun Pharmaceutical Industries Ltd. from selling generics.