After the FDA gave the green light to Sandoz Pharmaceuticals for its generic enoxaparin sodium injection ( Lovenox, Sanofi-Aventis), Sanofi hit the FDA with a lawsuit that urged the agency to revoke the approved abbreviated new drug application (ANDA).
Lovenox is an injection indicated to prevent deep vein thrombosis and for the prevention of complications linked to unstable angina and MI when administered with aspirin. Bridgewater, N.J.-based Sanofi alleged that the agency’s “approval of Sandoz’s ANDA for generic enoxaparin was arbitrary and capricious and otherwise unlawful under the Administrative Procedure Act.” Sanofi claims that the FDA approved the new drug application without requiring Sandoz to provide additional data concerning the drug’s safety and effectiveness.
Sanofi charged that the FDA “exceeded its authority” under the Federal Food, Drug, and Cosmetic Act by neglecting to ensure that Sandoz’s drug contains the same active ingredient as Lovenox.
“If not remedied, the FDA’s decision will cause Sanofi irreparable harm and may result in entry into the market of a generic product that is not clinically equivalent to Lovenox with respect to safety or efficacy,” Sanofi urged.
Additionally, Sanofi is claiming that the FDA approved the drug application despite the fact that other similar products have gone unapproved because the generic drugs have not been fully characterized. Sanofi said that the “FDA has failed to provide a substantive reason why generic enoxaparin should be treated differently from other drugs that cannot be fully characterized.”
Sanofi said, “Thus, the FDA has acted arbitrarily and capriciously by effectively according different treatment to similarly situated products.”
In 2003, Sanofi filed a citizen petition to the FDA that requested that until enoxaparin was fully characterized that the agency withhold approval of any new drug applications for Lovenox’s generic.
However, in a press release dated July 23, the FDA said, “The agency determined that current scientific evidence, precedent, and FDA’s legal authority establish a sound basis for the approval of generic enoxaparin sodium injection.”
“Before approving generic enoxaparin sodium injection, we expected, among other things, a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand name product,” said Keith Webber, PhD, deputy director of the FDA’s Office of Pharmaceutical Science.
Under the lawsuit, Sanofi is asking the U.S. District Court to provide:
- Judgment that the FDA acted “unlawfully in approving Sandoz’s ANDA";
- A restraining order and a preliminary injunction directing FDA to suspend and withdrawal its approval of the drug application; and
- An injunction for the terms stated above.
Sandoz is a division of Basel, Switzerland-based Novartis.