FDA Okays generic enoxaparin sodium injection

The Food and Drug Administration (United States) on July 23 approved the first generic version of Lovenox known as enoxaparin sodium injection indicated as an anti-coagulant drug or blood thinner to prevent conditions like deep vein thrombosis.

Levenox is made from heparin - a naturally derived mixture of sugar molecules and was approved in 1993.  The generic drug is expected to have the therapeutic effects as Levenox.

One common application of this drug is to prevent deep vein thrombosis or DVT, which is a blood clot formed in a vein deep in the body, particularly in the lower leg or thigh. Such a blood clot could otherwise lead to a sudden potentially fatal blockage in a lung artery - a condition known as a pulmonary embolism.

An estimated 100,000 cases of pulmonary embolism, the third largest killer in U.S. hospitals, occur each year in the U.S., the FDA said.

Approval of generic enoxaparin sodium injection is granted to Sandoz Inc. of Broomfield, Colo.

Sanofi-Aventis Pharmacueticals Inc filed a citizen petition asking the agency to withhold approval of any abbreviated new drug application (ANDA) for generic enoxaparin for injection unless certain conditions are met.

The FDA determined that "current scientific evidence, precedent, and FDA's legal authority establish a sound basis for the approval of generic enoxaparin sodium injection."

Keith Webber, Ph.D., Deputy Director, Office of Pharmaceutical Science Center for Drug Evaluation and Research, an agency under the FDA, on July 23 sent an approval letter to the manufacturer of the generic version of enoxaparin sodium injection.

Jimmy Downs